Vaginal Progesterone Improves Clinical Outcomes of RIF Patients

NCT ID: NCT06005207

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-12-31

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).

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaginal progesterone supplementation

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

Group Type: EXPERIMENTAL

progesterone vaginal sustained-release gel

Intervention Type: DRUG

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

Regular progesterone

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

progesterone vaginal sustained-release gel

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanjing University

OTHER

Sponsor Role: lead

Responsible Party

Li-jun Ding

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chenyang Huang

Role: CONTACT

dianshui19901562@126.com

+862583107188

Na Kong

Role: CONTACT

xtalkn@163.com

+862583107188

Facility Contacts

Chenyang Huang

Role: primary

dianshui19901562@126.com

+86 25 8310 7188

Other Identifiers

SZ-RIF-P-2023

Identifier Type: -

Identifier Source: org_study_id