Vaginal progesterone improves outcomes for women with repeated implantation failure

A Single-center Randomized Controlled Trial of Vaginal Progesterone to Improve Clinical Pregnancy Outcomes in Patients With Repeated Implantation Failure

This study is testing if adding vaginal progesterone to standard treatment can help women aged 20 to 40 who have had repeated implantation failures during frozen embryo transfers achieve successful pregnancies.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Nanjing University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06005207 on ClinicalTrials.gov

What this trial studies

This study is a single-center, randomized, controlled prospective investigation focusing on women aged 20 to 40 who have experienced repeated implantation failure (RIF) during frozen thawed embryo transfer (FET). Participants are randomly assigned to either receive vaginal progesterone or standard FET treatment to assess the impact on clinical pregnancy outcomes. The study aims to determine if the addition of vaginal progesterone can enhance the likelihood of successful pregnancies in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are women aged 20 to 40 with a BMI of 18-28 who have experienced repeated implantation failure with high-quality embryos.

Not a fit: Patients with recurrent pregnancy loss or those with specific adverse pregnancy histories may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve pregnancy rates for women facing repeated implantation failure.

How similar studies have performed: While the use of progesterone in fertility treatments is common, this specific approach targeting RIF patients is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Aged between 20 and 40 years old;
2. BMI: 18-28 kg/m2；
3. Consistent with the diagnosis of repeated implantation failure of unknown reasons, the previous embryo transfer situation meets one of the following:

   Total embryos transferred ≥ 4 high-quality cleavage-stage embryos; ≥ 2 blastocysts; ≥ 2 high quality cleavage-stage embryos +≥ 1 blastocysts;
4. At least 1 high-quality embryo remained for embryo transfer;
5. Volunteer to participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous abortions);
2. Adverse pregnancy history (stillbirth, fetal malformation, etc.);
3. Severe paternal factors: need for TESA or PESA;
4. PGT;
5. Failure of embryo implantation due to any definite reason, including but not limited to: endometrial adhesion (moderate to severe), thin endometrium (\<7 mm before transformation), endometritis, endometriosis (medium or severe), adenomyosis, untreated hydrosalpinx, hysteromyoma (submucosal fibroids, non submucosal fibroids \> 4.0 cm and/or endometrial compression), reproductive malformation, serious immune disease, serious coagulation function abnormality;
6. Chromosome abnormality of either spouse;
7. Those with contraindications to pregnancy or assisted reproductive technology.

Where this trial is running

Nanjing, Jiangsu

• Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Chenyang Huang

Conditions: Infertility, Female