NCT01614067

Delayed Start to Ovarian Stimulation

Delayed Start to Ovarian Stimulation Improves Oocyte Maturation and Quality: A Randomized Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In couples with infertility secondary to Diminished Ovarian Reserve, the investigators hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.

Detailed description

Over the past two decades, the success rate of assisted reproductive technology (ART) has dramatically increased. This increase is attributed to improvements in embryo culture, laboratory conditions, and optimization of ovarian stimulation protocols. Over the past years, there has been more interest in altering the ovarian stimulation protocol to improve outcomes. For example, recently our group found that a modification of ovulation trigger toward a more physiologic process improves oocyte quality and pregnancy outcomes. Others have suggested minimal stimulation improves in vitro fertilization (IVF) outcomes. The investigators propose to further investigate modifying the ovarian stimulation for women who have "decreased" ovarian reserve. The investigators propose that a delayed start to ovarian stimulation will improve oocyte maturation and quality and pregnancy outcomes. No published studies to date have evaluated if a delayed start to ovarian stimulation improves pregnancy outcomes. However, the investigators hypothesize that the use an antagonist for a delayed start of stimulation will work by one of two mechanisms: I. The partial suppression of FSH will allow for further recruitment of early antral follicles. II. The partial suppression of FSH will allow for further FSH responsiveness in existing follicles to synchronize the primary cohort, thereby increasing the total number of follicles.

Conditions

• Diminished Ovarian Reserve
• Infertility
• In Vitro Fertilization

Interventions

Type	Name	Description
DRUG	Ganirelix acetate	Subjects will receive 7 days of pre-treatment with the GnRH antagonist

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-07-01
• Completion: 2014-09-01
• First posted: 2012-06-07
• Last updated: 2021-06-15
• Results posted: 2021-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study