Progesterone supplementation for women with low progesterone levels during embryo transfer
Effectiveness of Progesterone Supplementation for Women Having Low Progesterone Levels on the Day of Frozen Embryo Transfer
This study is testing if adding an extra progesterone shot helps women with low progesterone levels have a successful pregnancy after a frozen embryo transfer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 824 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Tu Du Hospital Government |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT04897269 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare clinical pregnancy rates between two groups of women undergoing frozen embryo transfer who have progesterone levels below 10 ng/mL on transfer day. One group will receive vaginal micronized progesterone supplemented with intramuscular progesterone, while the other group will receive vaginal micronized progesterone without additional supplementation. The study is a single-center, randomized, controlled trial that will monitor various diagnostic and clinical outcomes throughout the process. Participants will be women aged 18-45 with normal BMI undergoing assisted reproductive technology.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with low progesterone levels undergoing frozen embryo transfer.
Not a fit: Patients with conditions such as uterine abnormalities, history of recurrent implantation failure, or those undergoing oocyte donation or surrogacy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve clinical pregnancy rates for women with low progesterone levels during embryo transfer.
How similar studies have performed: Previous studies have shown varying success with progesterone supplementation in similar contexts, but this specific approach is being evaluated in a controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergone ART with frozen embryo transfer, blastocyst or cleavaged stage embryo transfer, from 18-45 years of age * Normal BMI * HRT for Endometrial preparation in FET cycles Exclusion Criteria: * Oocyte donor cycles * Surrogacy * IVM * PGT * Abnormal Uterine (firbroids 0 -\> 3 according to FIGO classification, polyp, adenomyosis, congenital malformation) * Uterus fibroids type 4,5 (Figo classification) \> 4cm * History of recurrent implantation failure * Endometrial thickness \<7mm on the day of ET * Cesarean scar defect (isthmocele)
Where this trial is running
Ho Chi Minh City
- Department of Infertility of Tu Du hospital — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Principal investigator: Chau TM Le — Department of Infertility, Tu Du Hospital
- Study coordinator: Chau TM Le, PhD
- Email: dr.lethiminhchau@gmail.com
- Phone: +84908429006
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.