Home › Infertility › NCT07936227

Effect of Sirolimus on Oocyte Quality in Women Undergoing IVF

Pilot Study of Sirolimus for Cycle Priming to Improve Oocyte Quality in Women Undergoing IVF

Who can join

Ages 20 to 45 · Women

Inclusion Criteria:

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:

* \<50% maturity rate and/or \<50% IVM rate and/or \<70% fertilization rate
* Poor embryo quality, defined as:

  * Age 20-37 years: \>50% day-3 embryos poorer than 7C4
  * Age 38-45 years: \>50% day-3 embryos poorer than 6C3

In addition, inclusion criteria are:

* Known or unknown etiology of poor oocyte quality;
* Normal 46XX karyotype;
* Agreement to be monitored and treated as per the study protocol

Exclusion Criteria:

* Diminished ovarian reserve (AMH \<1.1 ng/mL)
* Poor response to prior ovarian stimulation, defined as:

  * Age 20-37 years: \< 6 oocytes retrieved in the previous cycle;
  * Age 38-45 years: \< 4 oocytes retrieved in the previous cycle;
* Severe male factor
* Karyotype abnormalities

About the study

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.

What is being tested

• Sirolimus (aka rapamycin) (drug)

Sponsor: Center for Human Reproduction · Participants: 20 · Started: Feb 25, 2026

Contact the study team

• David H. Barad, MD, MS · Phone: 212-994-4400

Official record on ClinicalTrials.gov — NCT07936227

Locations in the U.S.

Conditions

• Infertility

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.