Comparing live birth rates in natural cycle embryo transfers with and without hormone support
Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)
PHASE1 · ART Fertility Clinics LLC · NCT05969795
This study is testing if women can have the same chance of a live birth with a natural embryo transfer without hormone support as they do with hormone support.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 342 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | ART Fertility Clinics LLC (other) |
| Locations | 3 sites (Abu Dhabi and 2 other locations) |
| Trial ID | NCT05969795 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of single euploid embryo transfer in natural cycles (NC) without routine luteal phase support (LPS) compared to those with LPS. The goal is to determine if the live birth rate in NC cycles without LPS is non-inferior to those with LPS. If successful, this could simplify treatment protocols and enhance patient comfort. Participants will undergo transvaginal ultrasounds and serum hormone level monitoring as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 with regular ovulatory cycles and at least one euploid embryo available for transfer.
Not a fit: Patients with anatomical changes affecting implantation or a history of repeated pre-menstrual spotting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to simpler and more comfortable fertility treatments for women undergoing embryo transfer.
How similar studies have performed: Other studies have explored similar approaches, but this specific comparison of LPS in natural cycles is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18 to 40 years * Regular ovulatory cycles * Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6 * Detection of ovulation by P4 rise \> 1.0 ng/ml after LH surge * P4 value of at least 5 ng/ml on day 4 after ovulation Exclusion Criteria: * History of repeated pre-menstrual spotting * Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)
Where this trial is running
Abu Dhabi and 2 other locations
- ART Fertility Clinics LLC — Abu Dhabi, United Arab Emirates (RECRUITING)
- ART Fertility Clinics Al Ain — Al Ain City, United Arab Emirates (RECRUITING)
- ART Fertility Clinics Dubai — Dubai, United Arab Emirates (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Barbara Lawrenz, PhD — ART Fertility Clinics LLC
- Study coordinator: Barbara Lawrenz, PhD
- Email: barbara.lawrenz@artfertilityclinics.com
- Phone: +971 800 337845489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy Related, Infertility, Female, implantation rate, infertility, pregnancy rate, natural cycle, luteal phase support, live birth