Back to resultsA Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle
Primary Purpose
Infertility
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
progesterone
progesterone
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Aged 20 to 38 years.
- Less than three transfers.
- Undergoing HRT freeze-thaw cycle single blastocyst transfer in the current cycle.
- Having consented to participate in this study and signed the informed consent form.
Exclusion Criteria:
- Chromosomal abnormality in either the patient or their partner
- Contraindications to hormone replacement therapy.
- Patients with intramural myoma affecting the morphology of the uterine cavity, severe adenomyosis, endometriosis, congenital uterine anomalies, endometrial tuberculosis, intrauterine adhesion and other diseases significantly affecting embryonic implantation.
- Currently participating in another clinical study.
Sites / Locations
- Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Progesterone + 7
Progesterone + 6
Arm Description
the transfer of day 6 blastocyst on the 7th day of progesterone supplementation
the transfer of day 6 blastocysts on the 6th day of progesterone supplementation
Outcomes
Primary Outcome Measures
Embryo implantation rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04938011
Brief Title
A Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle
Official Title
A Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2024 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single-center, prospective, randomized controlled study. Patients with single blastocyst transfer in the freeze-thaw cycle, aged from 20 to 38 years, with less than three transfers, and with HRT-cycle single D6 blastocyst transfer in the current cycle were enrolled as the study participants. They were randomized into two groups using an Excel table, and the efficacy was evaluated in a blinded manner by a third party who was unaware of the grouping; the data summary phase was performed by blinded statistical analysis with triple separation of the investigator, operator, and statistician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Progesterone + 7
Arm Type
Experimental
Arm Description
the transfer of day 6 blastocyst on the 7th day of progesterone supplementation
Arm Title
Progesterone + 6
Arm Type
Active Comparator
Arm Description
the transfer of day 6 blastocysts on the 6th day of progesterone supplementation
Intervention Type
Drug
Intervention Name(s)
progesterone
Intervention Description
the transfer of day 6 blastocyst on the 6th day of progesterone supplementation
Intervention Type
Drug
Intervention Name(s)
progesterone
Intervention Description
the transfer of day 6 blastocyst on the 7th day of progesterone supplementation
Primary Outcome Measure Information:
Title
Embryo implantation rate
Time Frame
30 days after embryo transplantation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 20 to 38 years.
Less than three transfers.
Undergoing HRT freeze-thaw cycle single blastocyst transfer in the current cycle.
Having consented to participate in this study and signed the informed consent form.
Exclusion Criteria:
Chromosomal abnormality in either the patient or their partner
Contraindications to hormone replacement therapy.
Patients with intramural myoma affecting the morphology of the uterine cavity, severe adenomyosis, endometriosis, congenital uterine anomalies, endometrial tuberculosis, intrauterine adhesion and other diseases significantly affecting embryonic implantation.
Currently participating in another clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Jiang, PhD
Phone
025-83106666
Email
jiangyue85@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
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle
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