Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial

NCT00854373 | Completed Phase 4 Results DMC

• 1 other identifier: MR-9999
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

Marcelle Cedars, M.D., Victor Fujimoto, M.D., Mitch Rosen, M.D., Heather Huddleston, M.D., Paolo Rinaudo, M.D., Anthony Dobson, M.D., and Shehua Shen, M.D. from the UCSF Department of Obstetrics and Gynecology and Reproductive Sciences are conducting a study to learn about ovarian stimulation and oocyte maturation to improve fertilization, embryo quality, implantation and clinical pregnancy rates in patients undergoing in vitro fertilization (IVF). Two hormones, follicle stimulating hormone and human chorionic gonadotropin (FSH/hCG) will be compared to the standard one hormone, hCG, for the ovulation trigger. Over the past two decades, the success rate of assisted reproductive technology (ART) has dramatically increased. This increase has largely been attributed to improvements in the laboratory conditions and improvements in ovarian stimulation protocols (those medications used to increase the number of eggs maturing each cycle). Less work has been done on different ways to cause the final maturation of the eggs and the release of the egg from the ovary. The investigators propose to change the final injection prior to the egg retrieval (the ovulation trigger) so that it looks more like what happens in a normal menstrual cycle, where two hormones (both luteinizing hormone (LH) and FSH) increase. The investigators want to find out if this will improve egg quality and increase chances for pregnancy.

Conditions

Infertility

Keywords

Infertility; Pregnancy; in vitro fertilization

Outcome Measures

Primary Outcomes (1)

• Mean Fertilization Proportion (2PN/Oocytes Collected)

  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).

  24 hours after IVF or intracytoplasmic sperm injection (ICSI)

Secondary Outcomes (2)

• Mature Oocyte Recovery Rate Percentage

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

• Clinical Pregnancy Rate Percentage

  6 weeks after embryo transfer

Study Arms (2)

1

EXPERIMENTAL

Bravelle

Drug: Bravelle(follicle stimulating hormone)

2

PLACEBO COMPARATOR

Saline

Other: Saline ( placebo)

Interventions

Bravelle(follicle stimulating hormone) DRUG

One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.

1

Saline ( placebo) OTHER

1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing in vitro fertilization

You may not qualify if:

• risk of ovarian hyperstimulation syndrome

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF- Mission Bay

San Francisco, California, 94158, United States

Location

Related Publications (1)

• Lamb JD, Shen S, McCulloch C, Jalalian L, Cedars MI, Rosen MP. Follicle-stimulating hormone administered at the time of human chorionic gonadotropin trigger improves oocyte developmental competence in in vitro fertilization cycles: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2011 Apr;95(5):1655-60. doi: 10.1016/j.fertnstert.2011.01.019.

  PMID: 21315341 RESULT

MeSH Terms

Conditions

Infertility

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

This study was powered to detect difference in fertilization instead of pregnancy outcomes, because the number of patients required to detect a 10% absolute difference in pregnancy rates was too large to be completed at our center (n=387 per group).

Results Point of Contact

• Title: Mitchell P. Rosen, MD
• Organization: University of California, San Francisco

rosenm@obgyn.ucsf.edu

415-353-7475

Study Officials

• Mitchell P Rosen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 3, 2009
• Study Start: June 1, 2007
• Primary Completion: April 20, 2010
• Study Completion: April 20, 2010
• Last Updated: December 12, 2025
• Results First Posted: August 5, 2013

Record last verified: 2025-12

Locations

US (1)