Trial Outcomes & Findings for Study of Dual Trigger Ovulation in Oocyte Donors (NCT NCT01443546)

Results Overview

Any donor having a serious complication such as severe hyperstimulation syndrome, ovarian torsion, infection or peritoneal bleeding will be recorded

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

1 month

Results posted on

2019-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Human Chorionic Gonadotropin standard dose of hCG for ovulation trigger HCG: hCG Trigger	Lupron Trigger Leuprolide acetate 2 mg ovulation trigger Lupron Trigger: leuprolide acetate 2 mg SQ	Dual Trigger Lupron and hCG combined ovulation trigger Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).
Overall Study STARTED	9	9	8
Overall Study COMPLETED	9	9	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Dual Trigger Ovulation in Oocyte Donors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Human Chorionic Gonadotropin n=9 Participants standard dose of hCG for ovulation trigger HCG: hCG Trigger	Lupron Trigger n=9 Participants Leuprolide acetate 2 mg ovulation trigger Lupron Trigger: leuprolide acetate 2 mg SQ	Dual Trigger n=8 Participants Lupron and hCG combined ovulation trigger Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	9 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Total of 26 participants were enrolled. Number of subjects enrolled in each arm were below targeted numbers

Any donor having a serious complication such as severe hyperstimulation syndrome, ovarian torsion, infection or peritoneal bleeding will be recorded

Outcome measures

Outcome measures
Measure	hCG Trigger n=9 Participants standard dose of hCG for ovulation trigger HCG: hCG Trigger	Dual Trigger n=8 Participants Lupron and hCG combined ovulation trigger Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).	Lupron Trigger n=9 Participants Leuprolide acetate 2 mg ovulation trigger Lupron Trigger: leuprolide acetate 2 mg SQ
Number of Subjects Having Adverse Events	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: 7 days post retrieval

Population: Data was not completed by study participants so data was not analyzed for comparison

Subjects will complete a brief questionnaire on post retrieval day 7. They will state how many days after retrieval they were able to resume their usual activities.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 7 days post retrieval

Population: data for ovarian volume was not collected by 3D ultrasound

Ovarian volume of both ovaries will be measured by ultrasound on post op day number 7. Measurements will be taken in three different dimensions and volume calculated from those measurements.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day post ovulation

Population: Data was not completed by study participants so data was not analyzed for comparison

Number of mature oocytes retrieved will assess the efficacy of the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks post retrieval

Population: Data was not completed by study participants so data was not analyzed for comparison

Pregnancy rate per transfer will be assessed by hCG level on day 14 post retrieval and clinical pregnancy rate will be assessed by ultrasound on day 28 post retrieval. This will additionally assess efficacy of intervention.

Outcome measures

Outcome data not reported

Adverse Events

hCG Trigger

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dual Trigger

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Lupron Trigger

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	hCG Trigger n=9 participants at risk standard dose of hCG for ovulation trigger HCG: hCG Trigger	Dual Trigger n=8 participants at risk Lupron and hCG combined ovulation trigger Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).	Lupron Trigger n=9 participants at risk Leuprolide acetate 2 mg ovulation trigger Lupron Trigger: leuprolide acetate 2 mg SQ
Reproductive system and breast disorders Ovarian hyper stimulation	0.00% 0/9 • 1 month	12.5% 1/8 • 1 month	0.00% 0/9 • 1 month

Other adverse events

Other adverse events
Measure	hCG Trigger n=9 participants at risk standard dose of hCG for ovulation trigger HCG: hCG Trigger	Dual Trigger n=8 participants at risk Lupron and hCG combined ovulation trigger Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).	Lupron Trigger n=9 participants at risk Leuprolide acetate 2 mg ovulation trigger Lupron Trigger: leuprolide acetate 2 mg SQ
Reproductive system and breast disorders No oocytes retrieved	0.00% 0/9 • 1 month	0.00% 0/8 • 1 month	11.1% 1/9 • Number of events 1 • 1 month

Additional Information

Ina Cholst, MD

Weill Cornell Medical College

Phone: 646-962-3025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place