View Clinical Trial (Medical Research Study)
Delayed Start to Ovarian Stimulation Improves Oocyte Maturation and Quality: A Randomized Trial
| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94115 |
| Conditions: |
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Diminished Ovarian Reserve - Infertility - In Vitro Fertilization |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Antral Follicle Count (AFC) less than or equal to 4 as measured by transvaginal
ultrasound (TVUS), or
- Cancellation of a prior IVF cycle due to poor ovarian response.
- Patients will receive an antagonist stimulation protocol for IVF, or IVF with
Intracytoplasmic Sperm Injection (ICSI).
Exclusion Criteria:
- Severe male factor infertility requiring surgical intervention to obtain sperm
- Major uterine abnormality,
- Preimplantation genetic diagnostic (PGD) testing,
- Planned cycles without embryo transfer (for example, freeze-all, donor, or surrogate
cycles).
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| NCT ID: |
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NCT01614067 |
| Primary Contact: |
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Principal Investigator
Mitchell Rosen, MD
UCSF Center for Reproductive Health and Fertility Preservation
Thomas A Remble, DHS
Phone: 415-353-7394
Email: thomas.remble@ucsfmedctr.org
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| Backup Contact: |
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Email: lauri.green@ucsf.edu
Lauri Green, BS
Phone: 415-885-3598
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| Location Contact: |
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San Francisco, California 94115
United States
Thomas Remble, DHS
Phone: 415-353-7394
Email: thomas.remble@ucsfmedctr.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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