Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer

ConditionInfertility

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-35

SponsorKevin Doody

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent.

Female participant aged 18-35 years.

Diagnosis of infertility requiring IVF/ICSI, including unexplained infertility or mild male factor infertility.

BMI 18-30 kg/m².

Disqualifiers

Prior ovarian surgery.

Ovarian endometrioma.

Inaccessible ovaries.

Significant uterine factor expected to compromise implantation, pregnancy, or live birth.

Trial design

Design model

Single group

Treatments tested in this trial

CAPA-IVM System
Device
The CAPA-IVM System Kit will be used in the laboratory to support collection, handling, capacitation, and maturation of immature cumulus-oocyte complexes retrieved from visible 4-9 mm antral follicles.
Serial Unstimulated Transvaginal Oocyte Retrieval
Procedure/Surgery
Participants will undergo up to three unstimulated transvaginal oocyte retrievals targeting visible 4-9 mm antral follicles, without exogenous gonadotropin stimulation or ovulatory trigger medication.
ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo Transfer
Procedure/Surgery
Retrieved oocytes will undergo CAPA-IVM followed by ICSI, blastocyst culture, PGT-A, embryo vitrification/accumulation, and single euploid embryo transfer if a suitable euploid embryo is available.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Interventional, single-arm, prospective, open-label, adaptive pilot studyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Number of euploid embryos per retrieval

Number of euploid embryos per retrieval, assessed by PGT-A (Preimplantation Genetic Testing for Aneuploidy), with each participant serving as her own control across serial retrievals.

Time frame

From first egg retrieval to final PGT-A results, approximately 4 weeks.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kevin Doody

Lead sponsor

CARE Fertility Texas

Sponsor institution

Lavima Fertility

Collaborator

Source ClinicalTrials.gov

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