30 Participants NeededMy employer runs this trial

Hormone-Free Egg Retrieval for Infertility

(HARVEST Trial)

KD
Overseen ByKevin Doody, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Kevin Doody
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is testing whether eggs can be collected from small follicles without using the usual ovarian stimulation medications. Participants will have up to three egg retrieval procedures. The eggs collected during each retrieval will be matured in the laboratory using the CAPA-IVM (Capacitation In Vitro Maturation) process, fertilized, grown into embryos, and tested to identify chromosomally normal embryos.

Embryos from the retrievals may be frozen and accumulated. If a suitable embryo is available, one chromosomally normal embryo may be transferred. The study will also monitor safety, hormone levels, follicle development, embryo development, pregnancy results, and how well participants tolerate the study procedures.

Who Is on the Research Team?

KD

Kevin Doody, MD

Principal Investigator

CARE Fertility Texas

Are You a Good Fit for This Trial?

This trial is for people experiencing infertility who want to try having a baby using IVF, but without taking hormone stimulation medications. Participants should be able to undergo egg retrieval procedures and embryo transfer.

Inclusion Criteria

BMI 18-30 kg/m²
AFC ≥12
Basal FSH <8 IU/L
See 9 more

Exclusion Criteria

Current smoking or nicotine use within 3 months of screening
BMI <18 or >30 kg/m²
I have severe male infertility that needs surgical sperm retrieval.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Oocyte Retrieval and CAPA-IVM

Participants undergo up to three unstimulated transvaginal oocyte retrievals, followed by CAPA-IVM, ICSI, blastocyst culture, and PGT-A testing.

12 weeks
Multiple visits for each retrieval procedure

Embryo Transfer

Single euploid embryo transfer if a suitable embryo is available.

4 weeks

Follow-up

Participants are monitored for safety, hormone levels, follicle development, embryo development, and pregnancy results.

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests collecting eggs from small follicles without hormones, maturing them in the lab (CAPA-IVM), fertilizing with ICSI, growing embryos, testing for normal chromosomes (PGT-A), freezing embryos, and transferring one healthy embryo if available.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Interventional, single-arm, prospective, open-label, adaptive pilot studyExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kevin Doody

Lead Sponsor

Lavima Fertility

Collaborator