Trial Outcomes & Findings for The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment (NCT NCT01667406)

Results Overview

This was assessed by oocyte yield (percentage of mature \[metaphase 2; M2\] oocytes collected from the number of follicles ≥ 14 mm on final ultrasound scan prior to kisspeptin-54 trigger administration

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

175 participants

Primary outcome timeframe

36 hours post Kisspeptin-54 trigger injection

Results posted on

2021-06-08

Participant Flow

Parallel study, volunteers received only one type of dose

Participant milestones

Participant milestones
Measure	Kisspeptin-54 1.6 Single Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg	Kispeptin-54 3.2 Single Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg	Kisspeptin-54 6.4 Single Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg	Kisspeptin-54 12.8 Single Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg	OHSS - Kisspeptin-54 3.2 Single Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg	OHSS - Kisspeptin-54 6.4 Single Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg	OHSS - Kisspeptin-54 9.6 Single Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg	OHSS - Kisspeptin-54 12.8 Single Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg	Kisspeptin-54 9.6 + 9.6 Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later	Kisspeptin-54 9.6 + Saline Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
Overall Study STARTED	2	3	24	24	5	20	15	20	31	31
Overall Study COMPLETED	2	3	24	24	5	20	15	20	31	31
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kisspeptin-54 1.6 Single n=2 Participants Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg	Kispeptin-54 3.2 Single n=3 Participants Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg	Kisspeptin-54 6.4 Single n=24 Participants Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg	Kisspeptin-54 12.8 Single n=24 Participants Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg	OHSS - Kisspeptin-54 3.2 Single n=5 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg	OHSS - Kisspeptin-54 6.4 Single n=20 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg	OHSS - Kisspeptin-54 9.6 Single n=15 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg	OHSS - Kisspeptin-54 12.8 Single n=20 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg	Kisspeptin-54 9.6 + 9.6 n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later	Kisspeptin-54 9.6 + Saline n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later	Total n=175 Participants Total of all reporting groups
Age, Customized	30 years n=2 Participants	31 years n=3 Participants	32 years n=24 Participants	30 years n=24 Participants	30 years n=5 Participants	30 years n=20 Participants	32 years n=15 Participants	31 years n=20 Participants	30.9 years n=31 Participants	31.2 years n=31 Participants	31.1 years n=175 Participants
Sex: Female, Male Female	2 Participants n=2 Participants	3 Participants n=3 Participants	24 Participants n=24 Participants	24 Participants n=24 Participants	5 Participants n=5 Participants	20 Participants n=20 Participants	15 Participants n=15 Participants	20 Participants n=20 Participants	31 Participants n=31 Participants	31 Participants n=31 Participants	175 Participants n=175 Participants
Sex: Female, Male Male	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=15 Participants	0 Participants n=20 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=175 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	2 participants n=2 Participants	3 participants n=3 Participants	24 participants n=24 Participants	24 participants n=24 Participants	5 participants n=5 Participants	20 participants n=20 Participants	15 participants n=15 Participants	20 participants n=20 Participants	31 participants n=31 Participants	31 participants n=31 Participants	175 participants n=175 Participants
BMI 18-29	23 kg/m^2 STANDARD_DEVIATION 0.74 • n=2 Participants	22 kg/m^2 STANDARD_DEVIATION 0.74 • n=3 Participants	22 kg/m^2 STANDARD_DEVIATION 2.22 • n=24 Participants	23 kg/m^2 STANDARD_DEVIATION 1.48 • n=24 Participants	22 kg/m^2 STANDARD_DEVIATION 2.96 • n=5 Participants	22 kg/m^2 STANDARD_DEVIATION 5.19 • n=20 Participants	25 kg/m^2 STANDARD_DEVIATION 2.96 • n=15 Participants	24 kg/m^2 STANDARD_DEVIATION 5.19 • n=20 Participants	26.6 kg/m^2 STANDARD_DEVIATION 4.52 • n=31 Participants	23.9 kg/m^2 STANDARD_DEVIATION 4.074 • n=31 Participants	23.35 kg/m^2 STANDARD_DEVIATION 1.547 • n=175 Participants
Anti-mullerian hormone (AMH)	21 pmol/L STANDARD_DEVIATION 3.70 • n=2 Participants	13 pmol/L STANDARD_DEVIATION 5.19 • n=3 Participants	18 pmol/L STANDARD_DEVIATION 8.89 • n=24 Participants	21 pmol/L STANDARD_DEVIATION 9.63 • n=24 Participants	35 pmol/L STANDARD_DEVIATION 15.56 • n=5 Participants	48 pmol/L STANDARD_DEVIATION 22.22 • n=20 Participants	66 pmol/L STANDARD_DEVIATION 20.0 • n=15 Participants	53 pmol/L STANDARD_DEVIATION 18.52 • n=20 Participants	44 pmol/L STANDARD_DEVIATION 16.15 • n=31 Participants	52.4 pmol/L STANDARD_DEVIATION 33.33 • n=31 Participants	37.12 pmol/L STANDARD_DEVIATION 18.11 • n=175 Participants
Antral Follicle Count (AFC)	30 Follicles STANDARD_DEVIATION 2.22 • n=2 Participants	24 Follicles STANDARD_DEVIATION 5.93 • n=3 Participants	20 Follicles STANDARD_DEVIATION 7.41 • n=24 Participants	20 Follicles STANDARD_DEVIATION 6.67 • n=24 Participants	35 Follicles STANDARD_DEVIATION 15.56 • n=5 Participants	48 Follicles STANDARD_DEVIATION 2.22 • n=20 Participants	66 Follicles STANDARD_DEVIATION 20 • n=15 Participants	53 Follicles STANDARD_DEVIATION 18.52 • n=20 Participants	33 Follicles STANDARD_DEVIATION 8.89 • n=31 Participants	39 Follicles STANDARD_DEVIATION 16.30 • n=31 Participants	36.8 Follicles STANDARD_DEVIATION 15.05 • n=175 Participants

PRIMARY outcome

Timeframe: 36 hours post Kisspeptin-54 trigger injection

This was assessed by oocyte yield (percentage of mature \[metaphase 2; M2\] oocytes collected from the number of follicles ≥ 14 mm on final ultrasound scan prior to kisspeptin-54 trigger administration

Outcome measures

Outcome measures
Measure	Kisspeptin-54 1.6 Nmol/kg Single n=2 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.	Kisspeptin-54 3.2nmol/kg Single n=3 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54 6.4 Nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54 12.8nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 3.2nmol/Kg Single n=5 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 6.4nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 9.6nmol/Kg Single n=15 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 12.8nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54 OHSS, 9.6 + 9.6 n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later	Kisspeptin-54 OHSS, 9.6 + Saline n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
Percentage of Oocyte Maturation	49 percentage of expected oocyte yield Standard Deviation 29	36 percentage of expected oocyte yield Standard Deviation 18	76 percentage of expected oocyte yield Standard Deviation 49	103 percentage of expected oocyte yield Standard Deviation 53	53 percentage of expected oocyte yield Standard Deviation 41	86 percentage of expected oocyte yield Standard Deviation 49	86 percentage of expected oocyte yield Standard Deviation 74	121 percentage of expected oocyte yield Standard Deviation 119	55 percentage of expected oocyte yield Standard Deviation 18	46 percentage of expected oocyte yield Standard Deviation 22

SECONDARY outcome

Timeframe: 11 days after embryo transfer

Population: All participants

Number of participants achieving biochemical pregnancy by serum βhCG \> 10 mIU/mL

Outcome measures

Outcome measures
Measure	Kisspeptin-54 1.6 Nmol/kg Single n=2 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.	Kisspeptin-54 3.2nmol/kg Single n=3 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54 6.4 Nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54 12.8nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 3.2nmol/Kg Single n=5 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 6.4nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 9.6nmol/Kg Single n=15 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 12.8nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54 OHSS, 9.6 + 9.6 n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later	Kisspeptin-54 OHSS, 9.6 + Saline n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
Biochemical Pregnancy	1 Participants	1 Participants	11 Participants	8 Participants	1 Participants	10 Participants	10 Participants	6 Participants	16 Participants	10 Participants

SECONDARY outcome

Timeframe: 11 days following embryo transfer

Population: Occurence of OHSS was not analysed in the groups where number of participants analysed is zero as this first phase was to test only the hypothesis that kisspeptin-54 could be used to trigger egg maturation in women undergoing in vitro fertilization therapy.

Women were routinely screened for the development of early OHSS and late OHSS. Women were screened by symptoms, blood analysis, and ultrasound parameters

Outcome measures

Outcome measures
Measure	Kisspeptin-54 1.6 Nmol/kg Single Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.	Kisspeptin-54 3.2nmol/kg Single Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54 6.4 Nmol/kg Single Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54 12.8nmol/kg Single Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 3.2nmol/Kg Single n=5 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 6.4nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 9.6nmol/Kg Single n=15 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 12.8nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54 OHSS, 9.6 + 9.6 n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later	Kisspeptin-54 OHSS, 9.6 + Saline n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
Occurrence of OHSS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 days after oocyte retrieval

Population: All participants

Percentage of M2 oocytes that fertilize to form two pronuclear \[2PN\] zygotes following intracytoplasmic injection with sperm \[ICSI\]

Outcome measures

Outcome measures
Measure	Kisspeptin-54 1.6 Nmol/kg Single n=2 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.	Kisspeptin-54 3.2nmol/kg Single n=3 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54 6.4 Nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54 12.8nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 3.2nmol/Kg Single n=5 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 6.4nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 9.6nmol/Kg Single n=15 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 12.8nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54 OHSS, 9.6 + 9.6 n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later	Kisspeptin-54 OHSS, 9.6 + Saline n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
Fertilization Rate	14.28 percentage of 2PN zygotes Standard Deviation 20.20	58.33 percentage of 2PN zygotes Standard Deviation 30.04	66.94 percentage of 2PN zygotes Standard Deviation 26.98	76.01 percentage of 2PN zygotes Standard Deviation 26.28	68 percentage of 2PN zygotes Standard Deviation 39	76 percentage of 2PN zygotes Standard Deviation 29	74 percentage of 2PN zygotes Standard Deviation 33	73 percentage of 2PN zygotes Standard Deviation 21	78.6 percentage of 2PN zygotes Standard Deviation 26.2	78.9 percentage of 2PN zygotes Standard Deviation 37.7

SECONDARY outcome

Timeframe: 3 days after oocyte retrieval

Population: All participants

All embryos were graded at day 3 by an independent embryologist, blinded to doses of kisspeptin administered, using the British Fertility Society and Association of Clinical Embryologist embryo grading scheme for cleavage stage embryos, which describes embryos based on cell number, blastomere size, and fragmentation

Outcome measures

Outcome measures
Measure	Kisspeptin-54 1.6 Nmol/kg Single n=2 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.	Kisspeptin-54 3.2nmol/kg Single n=3 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54 6.4 Nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54 12.8nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 3.2nmol/Kg Single n=5 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 6.4nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 9.6nmol/Kg Single n=15 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 12.8nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54 OHSS, 9.6 + 9.6 n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later	Kisspeptin-54 OHSS, 9.6 + Saline n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
Embryo Formation	0 formed embryos Standard Deviation 0	2.33 formed embryos Standard Deviation 2.31	3.8 formed embryos Standard Deviation 2.7	4.5 formed embryos Standard Deviation 2.7	5.8 formed embryos Standard Deviation 4.8	9.4 formed embryos Standard Deviation 7	6.5 formed embryos Standard Deviation 5.6	11.1 formed embryos Standard Deviation 8.4	6 formed embryos Standard Deviation 4.44	5 formed embryos Standard Deviation 3.70

SECONDARY outcome

Timeframe: 6 weeks after embryo transfer

Population: All participants

Intrauterine gestational sac with heartbeat on ultrasound at 6 weeks' gestation

Outcome measures

Outcome measures
Measure	Kisspeptin-54 1.6 Nmol/kg Single n=2 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.	Kisspeptin-54 3.2nmol/kg Single n=3 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54 6.4 Nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54 12.8nmol/kg Single n=24 Participants Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 3.2nmol/Kg Single n=5 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 6.4nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 9.6nmol/Kg Single n=15 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection.	Kisspeptin-54, OHSS 12.8nmol/Kg Single n=20 Participants Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	Kisspeptin-54 OHSS, 9.6 + 9.6 n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later	Kisspeptin-54 OHSS, 9.6 + Saline n=31 Participants Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
Number of Participants With Clinical Pregnancy	1 Participants	0 Participants	7 Participants	4 Participants	1 Participants	10 Participants	10 Participants	6 Participants	7 Participants	12 Participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	KP-54 1.6nmol/kg Single n=2 participants at risk Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.	KP-54 3.2nmol/kg Single n=3 participants at risk Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	KP-54 6.4nmol/kg Single n=24 participants at risk Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	KP-54 12.8nmol/kg Single n=24 participants at risk Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	KP-54 OHSS 3.2nmol/kg Single n=5 participants at risk Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.	KP-54 OHSS 6.4nmol/kg Single n=20 participants at risk Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.	KP-54 OHSS 9.6nmol/kg Single n=15 participants at risk Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection.	KP-54 OHSS 12.8nmol/kg Single n=20 participants at risk Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.	KP-54 OHSS 9.6 + 9.6 Nmol/kg n=31 participants at risk Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later	KP-54 OHSS 9.6nmol/kg + Saline n=31 participants at risk Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/2 • 4 years	0.00% 0/3 • 4 years	4.2% 1/24 • Number of events 1 • 4 years	4.2% 1/24 • Number of events 1 • 4 years	0.00% 0/5 • 4 years	0.00% 0/20 • 4 years	13.3% 2/15 • Number of events 2 • 4 years	10.0% 2/20 • Number of events 2 • 4 years	0.00% 0/31 • 4 years	0.00% 0/31 • 4 years
Pregnancy, puerperium and perinatal conditions Miscarriage	0.00% 0/2 • 4 years	0.00% 0/3 • 4 years	4.2% 1/24 • Number of events 1 • 4 years	4.2% 1/24 • Number of events 1 • 4 years	0.00% 0/5 • 4 years	0.00% 0/20 • 4 years	13.3% 2/15 • Number of events 2 • 4 years	5.0% 1/20 • Number of events 1 • 4 years	0.00% 0/31 • 4 years	3.2% 1/31 • Number of events 1 • 4 years
Pregnancy, puerperium and perinatal conditions Heterotopic pregnancy	0.00% 0/2 • 4 years	0.00% 0/3 • 4 years	0.00% 0/24 • 4 years	4.2% 1/24 • Number of events 1 • 4 years	0.00% 0/5 • 4 years	0.00% 0/20 • 4 years	0.00% 0/15 • 4 years	0.00% 0/20 • 4 years	0.00% 0/31 • 4 years	0.00% 0/31 • 4 years
Reproductive system and breast disorders Still birth	0.00% 0/2 • 4 years	0.00% 0/3 • 4 years	0.00% 0/24 • 4 years	0.00% 0/24 • 4 years	0.00% 0/5 • 4 years	5.0% 1/20 • Number of events 1 • 4 years	0.00% 0/15 • 4 years	0.00% 0/20 • 4 years	0.00% 0/31 • 4 years	0.00% 0/31 • 4 years

Other adverse events

Adverse event data not reported

Additional Information

Professor Waljit Dhillo

Imperial College London

Phone: 442083833242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place