Vaginal Progesterone Improves Clinical Outcomes of RIF Patients

Nanjing University

Status: Enrolling

Conditions: Infertility, Female

Treatments: Drug: progesterone vaginal sustained-release gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06005207

SZ-RIF-P-2023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 152 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Vaginal progesterone supplementation

Experimental group

Description:

90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support

Treatment:

Drug: progesterone vaginal sustained-release gel

Regular progesterone

No Intervention group

Description:

No additional vaginal progesterone gel, routine endometrial transformation and luteal support drugs