Trial Outcomes & Findings for The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors (NCT NCT00867659)

Results Overview

evaluate by ultrasound examination, physical examination and blood work the incidence of ovarian hyperstimulation syndrome in oocyte donors receiving a single injection of 3 mg Cetrotide Acetate.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

4 weeks

Results posted on

2013-03-27

Participant Flow

Fertility practice. 20 oocyte donors completed the study bettwen 2009 and 2011

Long acting Cetrotide acetate was used in an attempt to prevent ovarian hyperstimulation syndrome.

Participant milestones

Participant milestones
Measure	Cetrotide Acetate oocyte donors will receive 3 mg cetrotide acetate by a single injection on the day of oocyte retrieval. The incidence of OHSS will be assessed.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetrotide Acetate n=20 Participants oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	25 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
incidence of ovarian hyperstimulation	20 particpants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

evaluate by ultrasound examination, physical examination and blood work the incidence of ovarian hyperstimulation syndrome in oocyte donors receiving a single injection of 3 mg Cetrotide Acetate.

Outcome measures

Outcome measures
Measure	Cetrotide Acetate n=20 Participants oocyte donors will receive a single injection of 3 mg cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS	10 cc (volume of ascites) Interval 0.0 to 90.0

PRIMARY outcome

Timeframe: 30 days

ultrasound measurements of both ovaries

Outcome measures

Outcome measures
Measure	Cetrotide Acetate n=20 Participants oocyte donors will receive a single injection of 3 mg cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
Ovarian Volumes as a Predictor of OHSS Severity	25 cc Interval 10.0 to 55.0

Adverse Events

Cetrotide Acetate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Fady Sharara

Virginia Center for Reproductive Medicine

Phone: 7034377722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place