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NCT01614067·Phase 4·INTERVENTIONAL

Delayed Start to Ovarian Stimulation

GanirelixOtherTerminated

Status

Terminated

Phase

Phase 4

Enrollment

30

Locations

1

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Ganirelix acetate

Subjects will receive 7 days of pre-treatment with the GnRH antagonist

Timeline

From registration to results.

  1. First posted

    Jun 7, 2012

  2. Study start

    May 2012

  3. Primary completion

    Jul 2014

  4. Study completion

    Sep 2014

  5. Results posted

    Jun 15, 2021

  6. Registry updated

    Jun 15, 2021

Outcomes

What the study measures.

Primary outcomes

Fertilization Proportions

Time frame · 8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization

Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval.

Number of Oocytes Retrieved

Time frame · up to 1 hour after oocytes retrieved

The egg retrieval procedure will be performed 36 hours after the ovulation trigger. The procedure is estimated to take up to 1 hour at study visit as part of routine care. The number of retrieved eggs will be counted

Secondary outcomes

Embryo Quality

Time frame · One hour on day 2 or 3 (following IVF procedure)

Embryo quality will be assessed by the embryologist on days 2 or 3 (Cleavage stage) following IVF using standard embryo grading criteria. Embryos grading is based on three criteria: the number of blastomere cells present in the embryo, the degree of observed cell fragmentation and the degree of observed symmetry of the cells.

Pregnancy Rates

Time frame · 2 to 3 weeks following embryo transfer

Beta HCG levels will be assessed at 2 weeks and 3 weeks after embryo transfer. A positive pregnancy is defined as two positive beta HCG levels (a value \> 5 mIU/ml ) observed over the time frame.

Stages of Oocyte Nuclear Maturation

Time frame · average of 1 to 2 hours on the Day of Retrieval

Quality of oocytes will be assessed for developmental stages (Germinal Vesicles, Meiosis I, or Meiosis II)

Number of Mature Follicles

Time frame · up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes)

Maturation of follicles will be assessed by measuring the size of follicles (mature \> 13mm) prior to (or at the time of) oocytes retrieval.

Oocyte Recovery Rate

Time frame · up to 1 hours after oocyte retrieval

The number of oocytes recovered at the time of oocyte retrieval following ovarian stimulation.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

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).

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

UCSF Center for Reproductive Health

San Francisco, California, United States

Publications

Results and literature.

PMID 21300334 ↗Blockeel C, Riva A, De Vos M, Haentjens P, Devroey P. Administration of a gonadotropin-releasing hormone antagonist during the 3 days before the initiation of the in vitro fertilization/intracytoplasmic sperm injection treatment cycle: impact on ovarian stimulation. A pilot study. Fertil Steril. 2011 Apr;95(5):1714-9.e1-2. doi: 10.1016/j.fertnstert.2011.01.028.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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