Delayed Start to Ovarian Stimulation

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diminished Ovarian Reserve Infertility In Vitro Fertilization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Delayed Start

Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.

Group Type EXPERIMENTAL

Ganirelix acetate

Intervention Type DRUG

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

Conventional Start

Ovarian stimulation with standard antagonist protocols (no delay).

Group Type ACTIVE_COMPARATOR

Ganirelix acetate

Intervention Type DRUG

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

Interventions

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Ganirelix acetate

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

Intervention Type DRUG

Other Intervention Names

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Ganirelix

Eligibility 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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No