Vaginal Progesterone Improves Clinical Outcomes of RIF Patients

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: progesterone vaginal sustained-release gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 20 and 40 years old; BMI: 18-28 kg/m2； 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; At least 1 high-quality embryo remained for embryo transfer; Volunteer to participate in the study and sign the informed consent form. Exclusion Criteria: Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous abortions); Adverse pregnancy history (stillbirth, fetal malformation, etc.); Severe paternal factors: need for TESA or PESA; PGT; 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; Chromosome abnormality of either spouse; Those with contraindications to pregnancy or assisted reproductive technology.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal progesterone supplementation<br>90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support | Drug: progesterone vaginal sustained-release gel<br>* 90 mg progesterone vaginal sustained-release gel is added daily during endometrial transformation and luteal support<br>|
| No Intervention: Regular progesterone<br>No additional vaginal progesterone gel, routine endometrial transformation and luteal support drugs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo implantation rate | The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate. | 45 days after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | 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. | 45 days after embryo transfer | 
| Early pregnancy loss rate | 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. | 12 weeks after embryo transfer | 
| Persistent pregnancy rate | The ratio of the number of pregnancies lasting to 20 weeks to the number of transplant cycles. | 20 weeks after embryo transfer | 
| Live birth rate | The ratio of the number of live fetal delivery cycles to the number of transplantation cycles after 28 weeks of pregnancy. | 40 weeks after embryo transfer |