Vaginal Progesterone Improves Clinical Outcomes of RIF Patients

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06005207
• Other study ID #: SZ-RIF-P-2023
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Nanjing University
• Contact: Chenyang Huang
• Phone: +862583107188
• Email: dianshui19901562[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
China	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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