Vaginal Progesterone Improves Clinical Outcomes of RIF Patients

Not Applicable

Recruiting

• Conditions: Infertility, Female
• Interventions: Drug: progesterone vaginal sustained-release gel

• Registration Number: NCT06005207
• Lead Sponsor: Nanjing University

Brief Summary

This study is a single-center, randomized, controlled prospective study. Those patients with repeated implantation failure (RIF) who will recieve frozen thawed embryo transfer (FET) are enrolled in the study. To determine the effect of vaginal progesterone on the clinical pregnancy outcomes of RIF patients.

Detailed Description

According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the vaginal progesterone added group (test group). Group B was the regular FET group (control group).

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-01
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Study First Posted: 2023-08-22
• Last Update Posted: 2023-08-22
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal progesterone supplementation	progesterone vaginal sustained-release gel	90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support

Primary Outcome Measures

Name	Time	Method
Embryo implantation rate	45 days after embryo transfer	The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.

Secondary Outcome Measures

Name	Time	Method
Early pregnancy loss rate	12 weeks after embryo transfer	The early pregnancy loss rate refers to the proportion of patients with pregnancy loss before 12 weeks of gestation in the total clinical pregnancy patients.
Persistent pregnancy rate	20 weeks after embryo transfer	The ratio of the number of pregnancies lasting to 20 weeks to the number of transplant cycles.
Clinical pregnancy rate	45 days after embryo transfer	Clinical pregnancy is defined as the presence of gestational sac observed by ultrasound. The proportion of clinical pregnancy cycles to total FET cycles is the clinical pregnancy rate.
Live birth rate	40 weeks after embryo transfer	The ratio of the number of live fetal delivery cycles to the number of transplantation cycles after 28 weeks of pregnancy.

Trial Locations

Locations (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China