Vaginal Progesterone Improves Clinical Outcomes of RIF Patients

• Sponsor: Nanjing University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06005207
• Collaborator: (none)
• Enrollment: 152
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Drug: progesterone vaginal sustained-release gel	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-center Randomized Controlled Trial of Vaginal Progesterone to Improve Clinical Pregnancy Outcomes in Patients With Repeated Implantation Failure
• Actual Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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;

1. At least 1 high-quality embryo remained for embryo transfer;

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008

Sponsors and Collaborators

• Nanjing University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li-jun Ding, principal investigator, Nanjing University
• ClinicalTrials.gov Identifier: NCT06005207
• Other Study ID Numbers: SZ-RIF-P-2023
• First Posted: Aug 22, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Infertility, Female; Progesterone

Study Results

No Results Posted as of Aug 22, 2023