Clinical trial NCT06005207: Vaginal Progesterone Improves Clinical Outcomes of RIF Patients
Official title: A Single-center Randomized Controlled Trial of Vaginal Progesterone to Improve Clinical Pregnancy Outcomes in Patients With Repeated Implantation Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 152
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Embryo implantation rate
timeFrame: 45 days after embryo transfer
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 45 days after embryo transfer
measure: Early pregnancy loss rate
timeFrame: 12 weeks after embryo transfer
measure: Persistent pregnancy rate
timeFrame: 20 weeks after embryo transfer
measure: Live birth rate
timeFrame: 40 weeks after embryo transfer
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References: