Increasing progesterone support for IVF patients with low hormone levels
Randomized Controlled Trial Comparing Micronized Progesterone (Amelgen ®) 400 mg BID Versus 400 mg TID for Luteal Support in Artificial Vitrified/Warmed Single Blastocyst Transfer Cycles With Low Progesterone on Day of Embryo Transfer
This study is testing if giving higher doses of vaginal progesterone to women with low hormone levels during IVF can help them have a successful pregnancy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 2 sites (Ghent and 1 other locations) |
| Trial ID | NCT04806919 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of higher doses of vaginal progesterone on ongoing pregnancy rates in patients undergoing in vitro fertilization (IVF) who have low serum progesterone levels on the day of blastocyst transfer. The study focuses on women aged 18 to 43 with a body mass index within a specified range and a history of fewer than four assisted reproductive technology cycles. Participants will receive progesterone three times daily to assess its effectiveness in improving pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 43 with a BMI between 18.5 and 35, undergoing a single vitrified/warmed embryo transfer and wishing to conceive.
Not a fit: Patients with known reasons for impaired implantation or those with a history of repeated miscarriages may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance pregnancy rates for women with low progesterone during IVF treatments.
How similar studies have performed: Previous studies have shown varying success with progesterone supplementation in IVF, making this approach a potentially valuable addition to existing treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent form (ICF) dated and signed * Age ≥ 18 and \< 43 years old * Body Mass Index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2 * Less than 4 previous Assisted Reproductive Technologies (ART) cycles * Current pregnancy wish * Patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (IVF or ICSI) Exclusion Criteria: * Simultaneous participation in another clinical study * Previous participation in this study * Known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis) * Repeated miscarriages (\> 2 miscarriages) * Untreated and uncontrolled thyroid dysfunction * Tumors of the ovary, breast, uterus, pituitary or hypothalamus * Abnormal vaginal bleeding without a known/diagnosed cause * Ovarian cysts or enlarged ovaries * Fibroid tumors of the uterus incompatible with pregnancy * Malformations of the reproductive organs incompatible with pregnancy * Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin) * Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia * Active smoking * Ongoing pregnancy * Use of carbamazepine, rifampicin or phenytoin * Those unable to comprehend the investigational nature of the proposed study
Where this trial is running
Ghent and 1 other locations
- UZ Ghent — Ghent, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Not_yet_recruiting)
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.