Unstimulated Egg Retrieval with CAPA-IVM and Euploid Embryo Transfer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label pilot study enrolling about 30 women with infertility to see if serial unstimulated transvaginal egg retrievals can yield mature eggs for CAPA-IVM, fertilization, and genetic testing of embryos. Embryos that are chromosomally normal will be accumulated for a potential single euploid embryo transfer, following vitrification and standard clinical practice. The study evaluates safety, hormone changes, follicle development, embryo outcomes, and patient tolerance across retrieval cycles, with a two-stage enrollment to adjust timing and feasibility based on interim findings. Eligible participants are women aged 18-35 with infertility, good ovarian reserve, and access to the required procedures. The trial is conducted at CARE Fertility Texas with lead sponsor Kevin Doody and collaborators Lavima Fertility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* AMH ≥2.5 ng/mL.
* AFC ≥12.
* Basal FSH \<8 IU/L.
* Ovaries accessible for transvaginal retrieval.
* Willing to undergo serial unstimulated TVORs with adaptive retrieval timing.
* Willing to undergo CAPA-IVM, ICSI, blastocyst culture, PGT-A, embryo vitrification/accumulation, and single euploid embryo transfer.
* Willing to undergo serial ultrasound and endocrine monitoring.
* Willing and able to comply with study procedures and follow-up.

Exclusion Criteria:

* Prior ovarian surgery.
* Ovarian endometrioma.
* Inaccessible ovaries.
* Significant uterine factor expected to compromise implantation, pregnancy, or live birth.
* Significant medical comorbidity that would increase risk of TVOR, pregnancy, or study participation.
* AMH \<2.5 ng/mL.
* AFC \<12.
* Basal FSH ≥8 IU/L.
* BMI \<18 or \>30 kg/m².
* Current smoking or nicotine use within 3 months of screening.
* Active pelvic infection, untreated STI, or acute urinary tract infection.
* Contraindication to transvaginal oocyte retrieval, anesthesia/sedation, pregnancy, or antibiotic prophylaxis.
* Known chromosomal abnormality in the participant or sperm source that would confound study outcome assessment.
* Severe male factor infertility requiring surgical sperm retrieval, unless specifically permitted by the final protocol.
* Recent exposure to teratogenic radiation, drugs, or toxins.
* Current participation in another interventional clinical trial that may confound outcomes.
* Previous participation in the CARE study.

Where it's running

• CARE Fertility Texas
  Bedford, Texas, United States Recruiting

Study contacts

• Principal investigator: Kevin Doody, MD — CARE Fertility Texas
• Study coordinator: Kevin Doody, MD
• Email: kevind@embryo.net
• Phone: 817-924-1572

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.