Trial Outcomes & Findings for Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial (NCT NCT00854373)

Results Overview

Number of normally fertilized oocytes (2PNs) divided by the total number of oocytes collected (i.e., not just the number of inseminated metaphase II state (MII) oocytes). This accounted for the possibility of both an enhanced oocyte maturation and improved fertilization of the mature oocytes. This also permitted inclusion of both IVF and intracytoplasmic sperm injection (ICSI) cycles in a way that allowed for evaluation of collective fertilization rates (i.e., typically, the denominator in IVF in calculating fertilization rate is all eggs collected, but in ICSI it is calculated using only the number of MII oocytes injected).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

232 participants

Primary outcome timeframe

24 hours after IVF or intracytoplasmic sperm injection (ICSI)

Results posted on

2025-12-12

Participant Flow

Women undergoing a long agonist suppression IVF protocol at one U.S. academic center were recruited to participate

Between June 2007 and March 2010, 232 participants consented for the study. Prior to randomization date, 44 participants were withdrawn from the study for failing to meet randomization criteria {21 cancelled treatment, 15 had elevated estrogen, 8 required a change in clinical treatment plan for which they no longer met eligibility criteria such as needing serrogacy, freezing all eggs or requiring Pre-Gestational Diagnosis}. 188 participants were randomized and included in the final analysis

Participant milestones

Participant milestones
Measure	Bravelle Bravelle Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.	Placebo Saline Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.
Overall Study STARTED	95	93
Overall Study COMPLETED	95	93
Overall Study NOT COMPLETED	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	Bravelle n=95 Participants Bravelle Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.	Placebo n=93 Participants Saline Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.	Total n=188 Participants Total of all reporting groups
Age, Categorical >=65 years	0 Participants n=95 Participants	0 Participants n=93 Participants	0 Participants n=188 Participants
Age, Categorical <=18 years	0 Participants n=95 Participants	0 Participants n=93 Participants	0 Participants n=188 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=95 Participants	93 Participants n=93 Participants	188 Participants n=188 Participants
Sex: Female, Male Female	95 Participants n=95 Participants	93 Participants n=93 Participants	188 Participants n=188 Participants
Sex: Female, Male Male	0 Participants n=95 Participants	0 Participants n=93 Participants	0 Participants n=188 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	95 participants n=95 Participants	93 participants n=93 Participants	188 participants n=188 Participants

PRIMARY outcome

Timeframe: 24 hours after IVF or intracytoplasmic sperm injection (ICSI)

Population: Intention to treat

Number of normally fertilized oocytes (2PNs) divided by the total number of oocytes collected (i.e., not just the number of inseminated metaphase II state (MII) oocytes). This accounted for the possibility of both an enhanced oocyte maturation and improved fertilization of the mature oocytes. This also permitted inclusion of both IVF and intracytoplasmic sperm injection (ICSI) cycles in a way that allowed for evaluation of collective fertilization rates (i.e., typically, the denominator in IVF in calculating fertilization rate is all eggs collected, but in ICSI it is calculated using only the number of MII oocytes injected).

Outcome measures

Outcome measures
Measure	Bravelle n=95 Participants Bravelle Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.	Placebo n=93 Participants Saline Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.
Mean Fertilization Proportion (2PN/Oocytes Collected)	0.63 proportion of oocytes fertilized Standard Deviation 0.21	0.55 proportion of oocytes fertilized Standard Deviation 0.21

SECONDARY outcome

Timeframe: From the ultrasound done on the HCG trigger date, until the oocyte retrieval time which is up to 36 hours after HCG administration

Likelihood of obtaining an oocyte from a single mature-sized follicle on each ovary. Mature follicles are usually 17mm in diameter or greater.

Outcome measures

Outcome measures
Measure	Bravelle n=95 Participants Bravelle Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.	Placebo n=93 Participants Saline Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.
Mature Oocyte Recovery Rate Percentage	69.9 percentage of follicles with egg	57.1 percentage of follicles with egg

SECONDARY outcome

Timeframe: 6 weeks after embryo transfer

The percentage of participants that achieve a clinical pregnancy as confirmed by Fetal heart motion by transvaginal ultrasound

Outcome measures

Outcome measures
Measure	Bravelle n=95 Participants Bravelle Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.	Placebo n=93 Participants Saline Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.
Clinical Pregnancy Rate Percentage	56.8 percentage of pregnant participants	46.2 percentage of pregnant participants

Adverse Events

Bravelle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Mitchell P. Rosen, MD

University of California, San Francisco

Phone: 415-353-7475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place