CompletedPhase 4

Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study

23 participantsStarted 2011-01

Plain-language summary

The purpose of the study is (A) to determine if the following novel approach improves the live birth rate with In-Vitro Fertilization (IVF) for women with a poor prognosis due to diminished ovarian reserve: * ovarian stimulation with medications that are effective in women with diminished ovarian reserve but adversely affect the endometrium * oocyte retrieval and vitrification * fertilization and embryo transfer in a subsequent cycle with controlled endometrial preparation B) To determine the optimal stimulation protocol for women with diminished ovarian reserve incorporating oocyte vitrification Women who are not eligible to participate in the Carolinas Medical Center (CMC) Assisted Reproductive Therapy program because of an extremely poor prognosis will be recruited for a prospective, randomized, open-label study to determine if a novel approach improves the live birth rate with traditional IVF "poor prognosis" stimulation protocols. The novel approach will incorporate one of two protocols utilizing medications that provide maximal ovarian stimulation but have a temporary detrimental fertility-reducing effect on the endometrium. If ovarian stimulation is adequate, oocyte retrieval will be performed and viable oocytes vitrified (stored in a "glass-like" state in liquid nitrogen). At a later time, oocyte warming and fertilization will be performed in a subsequent cycle, in which the endometrium has been prepared. Key points include: * Randomization to one of two ovarian stimulation protocols that have been shown to have a detrimental effect on the endometrium, and therefore are rarely used in a "fresh" IVF cycle * Oocyte vitrification is considered to be an investigational procedure by the American Society of Reproductive Medicine (ASRM), and should only be performed under the supervision of an IRB. With oocyte vitrification, ovarian stimulation and oocyte retrieval can "unlinked" from embryo transfer, allowing embryo transfer to occur in a more optimal environment * Endometrial preparation is routine for frozen embryo transfer

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Basal FSH 17 IU/mL (highest ever) * Basal FSH 15-17 (highest ever) and failed EFORT test * Age \> 43 at the time of expected retrieval * Failure to conceive with a prior "poor prognosis" IVF stimulation protocol (microdose leuprolide flare or GnRH antagonist cycle) if administered because of evidence of diminished ovarian reserve * Failure to conceive with 3 or more IVF cycles at CMC Exclusion Criteria: * Contraindications to IVF * Contraindication to pregnancy * Allergy or contraindication to medications used for IVF or embryo transfer * Use for a gestational carrier * Uncorrected or untreatable uterine infertility * Smoking or substance abuse within 3 months of initiating stimulation for IVF

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oocytes

Timeframe: up to 24 months

Trial details

NCT IDNCT01921166

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-11

Results submitted2015-02-09

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