Primary outcomeNumber· up to 24 months
Oocytes
| Group | Value (oocytes) |
|---|---|
| Clomiphene Plus Gonadotropins | 19 |
| Leuprolide Flare | 47 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataMaximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study
NCTNCT01921166 (opens ClinicalTrials.gov in a new tab)Other idDiminished Ovarian Reserve
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 23 participants (actual)
- Sponsor
- Wake Forest University Health Sciences · Other
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- Jan 2011
- Primary completion
- Nov 2011
- Completion
- Mar 2014
- First posted
- 13 Aug 2013 (estimated)
- Last update posted
- 2 Aug 2024
- Conditions
- Infertility
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20112012201320142015
- Ph 4
Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study
NCT01921166Jan 2011 to Mar 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- clomiphene plus gonadotropinsDrug
- Leuprolide flareDrug
Arms2
Active comparator
clomiphene plus gonadotropins
clomiphene plus gonadotropins
Active comparator
Leuprolide flare
Leuprolide flare
Primary outcomes1
Outcomes the sponsor listed as primary.
Oocytes
Time frame · up to 24 months
Registry description
Number of oocytes retrieved
Secondary outcomes(1)
Number of Oocytes Vitrified
Time frame · up to 24 months
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeNumber· up to 24 months
Number of Oocytes Vitrified
| Group | Value (oocytes) |
|---|---|
| Clomiphene Plus Gonadotropins | 19 |
| Leuprolide Flare | 47 |
Other pre specified outcome· up to 24 months
Number of Embryos From Vitrified Oocytes
| Group | Value |
|---|
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Clomiphene Plus Gonadotropinsclomiphene plus gonadotropins clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction | – | 0 / 8 | 0 / 8 |
| Leuprolide FlareLeuprolide flare Leuprolide flare: Leuprolide flare ovulation induction | – | 0 / 15 | 0 / 15 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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