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Clinical trialNCT01921166CompletedPhase 4Interventional

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

SponsorWake Forest University Health SciencesEnrollment23Infertility
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

Investigators

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Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Leuprolide flareClomiphene plus gonadotropins
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2011
Primary completion
30 Nov 2011
Completion
31 Mar 2014
Last update posted
2 Aug 2024
Registered enrollment
23
Registry id
NCT01921166

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.