Phase 4
N=23
Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01921166 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Oocytes — 19; 47 oocytes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- clomiphene plus gonadotropins (Drug); Leuprolide flare (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oocytes |
19; 47 | — |
| SECONDARY Number of Oocytes Vitrified |
19; 47 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01921166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.