The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
NCT ID: NCT01667406
Last Updated: 2021-06-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
175 participants
INTERVENTIONAL
2012-06-01
2016-10-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reproductive Hormones During Sustained Administration of Kisspeptin
NCT02081924
Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality
NCT03139474
GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET
NCT04064840
Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles
NCT06150703
Antagonist Protocol in IVF
NCT02335736
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Oocytes will be retrieved and graded by an embryologist to see whether or not they have matured.
The reproductive hormones Luteinising hormone, follicle stimulating hormone, oestradiol and progesterone will also be measured
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Kisspeptin 1.6nmol/kg
single kisspeptin dose 1.6 nmol/kg subcutaneously
Kisspeptin-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 3.2nmol/kg
single kisspeptin dose 3.2 nmol/kg subcutaneously
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 6.4nmol/kg
single kisspeptin dose 6.4 nmol/kg subcutaneously
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
Kisspeptin 12.8nmol/kg
single kisspeptin dose 12.8 nmol/kg subcutaneously
Kisspeptin-54 OHSS, 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
Kisspeptin 3.2nmol/kg
single kisspeptin dose 3.2 nmol/kg subcutaneously
Kisspeptin-54 OHSS, 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
Kisspeptin 6.4nmol/kg
single kisspeptin dose 6.4 nmol/kg subcutaneously
Kisspeptin-54 OHSS, 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
Kisspeptin 9.6nmol/kg
single kisspeptin dose 9.6 nmol/kg subcutaneously
Kisspeptin-54 OHSS, 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 12.8nmol/kg
single kisspeptin dose 12.8 nmol/kg subcutaneously
Kisspeptin-54 OHSS, 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 9.6 nmol/kg double
kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously
Kisspeptin-54 OHSS, 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
Kisspeptin 9.6 nmol/kg + saline
kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Kisspeptin 1.6nmol/kg
single kisspeptin dose 1.6 nmol/kg subcutaneously
Kisspeptin 3.2nmol/kg
single kisspeptin dose 3.2 nmol/kg subcutaneously
Kisspeptin 6.4nmol/kg
single kisspeptin dose 6.4 nmol/kg subcutaneously
Kisspeptin 9.6nmol/kg
single kisspeptin dose 9.6 nmol/kg subcutaneously
Kisspeptin 12.8nmol/kg
single kisspeptin dose 12.8 nmol/kg subcutaneously
Kisspeptin 9.6 nmol/kg double
kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously
Kisspeptin 9.6 nmol/kg + saline
kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index between 18 and 29 kg/m2
* Stable body weight for at least 3 months
* Normal early menstrual cycle follicular phase serum FSH concentration
* Serum anti-Mullerian hormone (AMH) \> 40pmol/L
* No more than one previous IVF treatment cycle
* Both ovaries intact
Exclusion Criteria
* Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study
* Treatment with an investigational drug within the preceding 2 months
* Donated blood during the preceding 3 months or intention to do so before the end of the study
* Previous poor response to IVF treatment
18 Years
34 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Waljit S Dhillo, PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hammersmith Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jayasena CN, Abbara A, Comninos AN, Nijher GM, Christopoulos G, Narayanaswamy S, Izzi-Engbeaya C, Sridharan M, Mason AJ, Warwick J, Ashby D, Ghatei MA, Bloom SR, Carby A, Trew GH, Dhillo WS. Kisspeptin-54 triggers egg maturation in women undergoing in vitro fertilization. J Clin Invest. 2014 Aug;124(8):3667-77. doi: 10.1172/JCI75730. Epub 2014 Jul 18.
Abbara A, Clarke S, Islam R, Prague JK, Comninos AN, Narayanaswamy S, Papadopoulou D, Roberts R, Izzi-Engbeaya C, Ratnasabapathy R, Nesbitt A, Vimalesvaran S, Salim R, Lavery SA, Bloom SR, Huson L, Trew GH, Dhillo WS. A second dose of kisspeptin-54 improves oocyte maturation in women at high risk of ovarian hyperstimulation syndrome: a Phase 2 randomized controlled trial. Hum Reprod. 2017 Sep 1;32(9):1915-1924. doi: 10.1093/humrep/dex253.
Abbara A, Jayasena CN, Christopoulos G, Narayanaswamy S, Izzi-Engbeaya C, Nijher GM, Comninos AN, Peters D, Buckley A, Ratnasabapathy R, Prague JK, Salim R, Lavery SA, Bloom SR, Szigeti M, Ashby DA, Trew GH, Dhillo WS. Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy. J Clin Endocrinol Metab. 2015 Sep;100(9):3322-31. doi: 10.1210/jc.2015-2332. Epub 2015 Jul 20.
Abbara A, Islam R, Clarke SA, Jeffers L, Christopoulos G, Comninos AN, Salim R, Lavery SA, Vuong TNL, Humaidan P, Kelsey TW, Trew GH, Dhillo WS. Clinical parameters of ovarian hyperstimulation syndrome following different hormonal triggers of oocyte maturation in IVF treatment. Clin Endocrinol (Oxf). 2018 Jun;88(6):920-927. doi: 10.1111/cen.13569. Epub 2018 Mar 6.
Owens LA, Abbara A, Lerner A, O'floinn S, Christopoulos G, Khanjani S, Islam R, Hardy K, Hanyaloglu AC, Lavery SA, Dhillo WS, Franks S. The direct and indirect effects of kisspeptin-54 on granulosa lutein cell function. Hum Reprod. 2018 Feb 1;33(2):292-302. doi: 10.1093/humrep/dex357.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-000154-61
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13HH0199
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.