Using hCG to trigger a corpus luteum before a thawed embryo transfer

The Role of hCG in Thawed Embryo Transfer

This trial will test whether giving a single hCG injection to create a corpus luteum helps people have better success with a thawed embryo transfer.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fertility Center of Las Vegas (Industry-sponsored)
• Locations: 1 site (Las Vegas, Nevada)
• Trial ID: NCT07004192 on ClinicalTrials.gov

What this trial studies

This is a prospective randomized trial that assigns adults undergoing thawed blastocyst transfer to one of two arms that differ only by whether they receive an hCG injection to induce a corpus luteum. All other medications and transfer procedures are kept identical between groups to isolate the effect of the corpus luteum. Pregnancy and implantation outcomes after the transfer will be followed to compare the two approaches. The protocol allows use of PGT, donor gametes, and gestational carriers while excluding patients with indications for anticoagulation or embryos frozen at another center.

Who should consider this trial

Good fit: Adult, non‑menopausal women planning transfer of at least one thawed blastocyst of transferable quality who can provide informed consent in English and attend the Fertility Center of Las Vegas are ideal candidates.

Not a fit: Patients under 18, those using embryos frozen at another center, those requiring anticoagulation in pregnancy (for example due to antiphospholipid syndrome), patients insisting on a two-embryo transfer, or those unable to consent in English are not eligible and therefore unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could show whether inducing a corpus luteum with hCG increases pregnancy or live birth rates after thawed embryo transfer, helping clinicians optimize luteal support.

How similar studies have performed: Some prior observational and randomized work suggests the presence of a corpus luteum can affect outcomes after frozen embryo transfer, but randomized trials that use hCG as the sole differing intervention are limited and have shown mixed results.

Eligibility criteria

Inclusion Criteria:

1. Female adult expecting to receive transfer of a thawed embryo.
2. At least one available frozen blastocyst of transferrable quality.
3. Non-menopausal female with at least one antral follicle.
4. Use of pre-implantation genetic testing (PGT), embryos derived from donor oocytes and/or donor sperm, a gestational carrier, and history of prior transfer(s) regardless of outcome are allowed.
5. Subsequent embryo transfers after failed transfers under this study are allowed, but not after a transfer that has resulted in ongoing pregnancy at ten weeks gestation under this study.

Exclusion Criteria:

1. Minors (age\<18 years).
2. Use of embryo(s) frozen at another center.
3. Patient insistent on transfer of two embryos.
4. Patient or partner unable to provide informed consent in English.
5. Patient already enrolled in any other research study for her embryo transfer.
6. History of anti-phospholipid syndrome or any other indication for use of Lovenox in pregnancy.
7. Patient for whom the physician assesses this protocol is inappropriate or unsafe.

Where this trial is running

Las Vegas, Nevada

• Fertility Center of Las Vegas — Las Vegas, Nevada, United States (Recruiting)

Study contacts

• Study coordinator: Shironda Research Assistant

Conditions Infertility; Thawed embryo transfer