Back to resultsVaginal Progesterone Improves Clinical Outcomes of RIF Patients
Primary Purpose
Infertility, Female
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
progesterone vaginal sustained-release gel
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility Criteria
Inclusion Criteria: Aged between 20 and 40 years old; BMI: 18-28 kg/m2； 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; At least 1 high-quality embryo remained for embryo transfer; Volunteer to participate in the study and sign the informed consent form. Exclusion Criteria: Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous abortions); Adverse pregnancy history (stillbirth, fetal malformation, etc.); Severe paternal factors: need for TESA or PESA; PGT; 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; Chromosome abnormality of either spouse; Those with contraindications to pregnancy or assisted reproductive technology.
Sites / Locations
- Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vaginal progesterone supplementation
Regular progesterone
Arm Description
90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support
No additional vaginal progesterone gel, routine endometrial transformation and luteal support drugs
Outcomes
Primary Outcome Measures
Embryo implantation rate
The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.
Secondary Outcome Measures
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.
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.
Persistent pregnancy rate
The ratio of the number of pregnancies lasting to 20 weeks to the number of transplant cycles.
Live birth rate
The ratio of the number of live fetal delivery cycles to the number of transplantation cycles after 28 weeks of pregnancy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06005207
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaginal progesterone supplementation
Arm Type
Experimental
Arm Description
90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support
Arm Title
Regular progesterone
Arm Type
No Intervention
Arm Description
No additional vaginal progesterone gel, routine endometrial transformation and luteal support drugs
Intervention Type
Drug
Intervention Name(s)
progesterone vaginal sustained-release gel
Intervention Description
90 mg progesterone vaginal sustained-release gel is added daily during endometrial transformation and luteal support
Primary Outcome Measure Information:
Title
Embryo implantation rate
Description
The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.
Time Frame
45 days after embryo transfer
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
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.
Time Frame
45 days after embryo transfer
Title
Early pregnancy loss rate
Description
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.
Time Frame
12 weeks after embryo transfer
Title
Persistent pregnancy rate
Description
The ratio of the number of pregnancies lasting to 20 weeks to the number of transplant cycles.
Time Frame
20 weeks after embryo transfer
Title
Live birth rate
Description
The ratio of the number of live fetal delivery cycles to the number of transplantation cycles after 28 weeks of pregnancy.
Time Frame
40 weeks after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 20 and 40 years old;
BMI: 18-28 kg/m2；
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;
At least 1 high-quality embryo remained for embryo transfer;
Volunteer to participate in the study and sign the informed consent form.
Exclusion Criteria:
Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous abortions);
Adverse pregnancy history (stillbirth, fetal malformation, etc.);
Severe paternal factors: need for TESA or PESA;
PGT;
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;
Chromosome abnormality of either spouse;
Those with contraindications to pregnancy or assisted reproductive technology.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenyang Huang
Phone
+862583107188
Email
dianshui19901562@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Na Kong
Phone
+862583107188
Email
xtalkn@163.com
Facility Information:
Facility Name
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenyang Huang
Phone
+86 25 8310 7188
Email
dianshui19901562@126.com
12. IPD Sharing Statement
Learn more about this trial
Vaginal Progesterone Improves Clinical Outcomes of RIF Patients
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