A Phase 4 interventional study of Sirolimus (aka rapamycin) in Oocytes, Oocyte Competence and Oocyte Retrieval for IVF, sponsored by Center for Human Reproduction. Recruiting at 1 site in United States. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Center for Human Reproduction · Phase 4, Interventional, and Treatment
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Among 395 studies in Infertility with a site in United States — 63 open to participants now, 85 under way, 7 of them phase 3. Infertility · United States.
Among the 395 studies in Infertility with a site in United States, this one is the 202nd largest by planned enrollment of the 274 interventional ones that give a count, is one of 17 that started in 2026, is one of 35 in phase 4, reaches primary completion later than 64 of the 83 other live ones, and was the 395th registered.
2,088 studies on the registry are indexed under Infertility; 356 are open to participants now.
Browse Infertility studies →63 of the 395 studies in Infertility with a site in United States are open now. Recruiting first, the newest first:
Abigail Mancuso · Sites in United States
Ages 18–45
Brigham and Women's Hospital · Sites in United States
Ages 18–40 · Women only · Healthy volunteers
University of Oklahoma · Sites in United States
Ages 18–45 · Women only
Kevin Doody · Sites in United States
Ages 18–35 · Women only
Reproductive Medicine Associates of New Jersey · Sites in United States
Ages 18–42 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 234 Infertility studies recruiting now, 43 (18%) set no upper age limit and 185 (79%) stop at 75 or younger; 27 take children under 18; 76 take healthy volunteers.
This study: 20 Years to 45 Years · female · no healthy volunteers.
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395 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 32 · Phase 3 31 · Phase 4 35
First in 1989; this study’s year is marked. 17 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 134 across 1,414 interventional studies indexed under Infertility.
Median enrollment 89 across the 274 interventional studies, 150 across the 119 observational. Of the 251 that completed or were terminated, 57 (23%) have results posted.
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91 of 395 have an industry lead sponsor. The 10 most frequent:
Center for Human Reproduction is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Center for Human Reproduction has 6 studies filed under Infertility — fewer than ten, so there is no comparison to draw.
25 of the studies in Infertility with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06375811Phase 3Yale UniversityPre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp | 2027-03-31 |
| NCT06858111Phase 3Gameto, Inc.Fertilo In Vitro Research Study and Trial | 2027-05 |
| NCT04544462Genomic Prediction Inc.ANXA5 M2 Haplotyping in IVF Patients and Embryos | 2026-11 |
| NCT07226310University of OklahomaThe Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study | 2026-12 |
| NCT07083700Inception Fertility Research Institute, LLCFrame Support Study | 2026-12 |
Add all 25 to your calendar (.ics) → With an account.
Among the 395 studies in Infertility with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Poor oocyte (egg before maturation) quality remains a major barrier to IVF success, particularly in women with prior cycles demonstrating low oocyte maturity, poor fertilization rates, or suboptimal embryo development. Preclinical and early clinical evidence suggests that the mTOR pathway plays a critical role in oocyte and follicular development, and pharmacologic inhibition with sirolimus (also known as rapamycin), may improve oocyte competence by adjusting granulosa cell function and follicular aging processes.
We propose a multicenter pilot study enrolling participants at the Center for Human Reproduction (CHR) in New York and at the Division of Reproductive Endocrinology and Infertility at the University of Miami Miller School of Medicine. Participants will be aged 20-45 years with a documented history of poor oocyte quality in at least one prior IVF cycle, defined by low oocyte maturity (\<50%), low IVM rates (\<50%), poor fertilization (\<70%), or suboptimal embryo quality (\<50% cleavage-stage embryos or no embryos graded B4 or higher), despite normal ovarian response for age and reserve. After enrollment, participants will undergo ovarian priming with Sirolimus 1 mg orally daily in late luteal phase (from cycle-day 19-21 until menstrual period, hence for a total of 7-10 days), immediately preceding ovarian stimulation for embryo banking and later embryo transfer (after at least 12 weeks).
The primary objective is to evaluate the feasibility, safety, and preliminary efficacy of short-term sirolimus treatment for cycle priming prior to IVF, with the goal of improving oocyte quality and developmental competence. The main outcome will be embryo quality compared with historical cycles, although other secondary outcomes derived from egg quality will be assessed.
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Women eligible for participation in this study will be recruited at the Center for Human Reproduction (CHR) in New York at the Division of Reproductive Endocrinology and Infertility at the University of Miami Miller School of Medicine. Participants must be aged 20-45, have a normal ovarian reserve (≥1.1 ng/mL), and a history of poor oocyte quality observed in at least one prior IVF cycle, defined as:
Poor embryo quality, defined as:
In addition, inclusion criteria are:
Exclusion Criteria:
Poor response to prior ovarian stimulation, defined as:
This is a prospective, single-arm, stratified pilot study with two prespecified age strata: Age 20-37 -No Qualifying embryos AND Age 38-45 -No Qualifying embryos. A total of 20 participants will be enrolled at the CHR, 10 per age stratum.
Drug: Sirolimus (aka rapamycin)
Ovarian priming with Sirolimus 1 mg orally daily in late luteal phase (from cycle-day 19-21 until menstrual period, hence for a total of 7-10 days), immediately preceding ovarian stimulation for embryo banking and later embryo transfer (after at least 12 weeks).
Responder vs. non-responder to rapamycin priming
Binary outcome defined as responder vs. non-responder to rapamycin priming in the post-intervention cycle. A "responder" is defined as achieving at least one Day-3 embryo that meets the prespecified qualifying embryo criteria outlined below. * Age 20-37 years: at least 7C4 (≥7 cells and fragmentation grade ≥4, any cell symmetry grade A/B/C) * Age 38-45 years: at least 6C3 (≥6 cells and fragmentation grade ≥3, any cell symmetry grade A/B/C)
Time frame: Ovarian priming 7-10 days, immediately preceding ovarian stimulation for embryo banking and later embryo transfer (after at least 12 weeks)
Number of qualifying Day-3 embryos per cycle, distribution of Day-3 cell number and combined morphology grades
• And if available: Day-5 development metrics and clinical outcomes (reported descriptively only)
Time frame: Ovarian priming 7-10 days, immediately preceding ovarian stimulation for embryo banking and later embryo transfer (after at least 12 weeks)
Started Feb 2026 (actual). Primary completion is estimated for Feb 2029, 36 months after the start.
Of 74 non-industry phase 4 interventional studies under Infertility, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 82. This study's planned 36 months is close to that.
Counting every sponsor, half of 81 studies reached it within 33 months; a quarter within 19 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Center for Human Reproduction