Back to resultsHMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients
Primary Purpose
Infertility, Female, Intrauterine Adhesion
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
human menopausal gonadotrophin
hormone replacement therapy
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility Criteria
Inclusion Criteria:
- BMI 18~23 kg/m2
- Women with moderate to severe IUA as defined by the American Fertility Society classification (1988)
- Presence of at least 3 cryopreserved cleavage-stage embryos (including 1 good quality) or blastocysts
Exclusion Criteria:
- Using embryos from donor oocytes
- Preimplantation genetic diagnosis(PGD)/Preimplantation genetic screening(PGS) cycles
- Moderate or severe endometriosis
- Untreated unilateral or bilateral hydrosalpinx
- Uterine adenomyosis, uterine myoma (submucous,intramural myoma >4 cm),>1cm septate uterus, double uterus, bicornuate uterus, unicornuate uterus
Sites / Locations
- Reproductive & Genetic Hospital of CITIC-XIANGYA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental-HMG stimulation group
Control-HRT group
Arm Description
Women will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer
Women will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer
Outcomes
Primary Outcome Measures
Ongoing pregnancy rate
Ongoing pregnancy is defined as the presence of a gestational sac with foetal heartbeat by transvaginal ultrasound at 10th week after embryo transfer（ET）
Secondary Outcome Measures
Cycle cancellation rate
Implantation rate
Sacs seen in early ultrasound divided by the number of embryos transferred
Clinical pregnancy rate
Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers
Early miscarriage rate
Number of losses of clinical pregnancies divided by number of clinical pregnancies
Biochemical pregnancy rate
number of pregnancies with a transient elevation of serum human chorionic gonadotropin(β-hCG) level (>10 mIU/ml) divided by number of embryo transfers
Full Information
NCT ID
NCT03578172
First Posted
June 24, 2018
Last Updated
January 9, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
1. Study Identification
Unique Protocol Identification Number
NCT03578172
Brief Title
HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients
Official Title
Randomized, Controlled Trial to Assess the Efficacy of Human Menopausal Gonadotrophin Stimulation and Hormone Replacement Therapy for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe Intrauterine Adhesion Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
October 20, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Intrauterine Adhesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental-HMG stimulation group
Arm Type
Experimental
Arm Description
Women will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer
Arm Title
Control-HRT group
Arm Type
Active Comparator
Arm Description
Women will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer
Intervention Type
Drug
Intervention Name(s)
human menopausal gonadotrophin
Intervention Description
experimental group:Women will be given HMG 37.5-150IU daily followed by monitoring of the follicular growth (folliculometry) when serum Estradiol (E2)<100pg/ml，progesterone (P)<1ng/ml. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle ≥20mm in diameter followed by luteal phase support (using progesterone supplements) after 24 hours.
Intervention Type
Drug
Intervention Name(s)
hormone replacement therapy
Intervention Description
Women will be given 17 β-estradiol hemihydrate 2 mg and estrogen gel 5 g daily from day 3 of the cycle then the endometrial thickness will be assessed on day 7 by transvaginal sonography (TVS). If the endometrium is ≥ 9 mm, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 9 mm, estradiol will be continued until reaching appropriate endometrial thickness and then the luteal phase support will be started. The cycle will be cancelled If the estradiol administration >60 days.
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Description
Ongoing pregnancy is defined as the presence of a gestational sac with foetal heartbeat by transvaginal ultrasound at 10th week after embryo transfer（ET）
Time Frame
10th week after embryo transfer
Secondary Outcome Measure Information:
Title
Cycle cancellation rate
Time Frame
the day of embryo transfer
Title
Implantation rate
Description
Sacs seen in early ultrasound divided by the number of embryos transferred
Time Frame
4th weeks after embryo transfer
Title
Clinical pregnancy rate
Description
Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers
Time Frame
4th weeks after embryo transfer
Title
Early miscarriage rate
Description
Number of losses of clinical pregnancies divided by number of clinical pregnancies
Time Frame
12th weeks gestational age
Title
Biochemical pregnancy rate
Description
number of pregnancies with a transient elevation of serum human chorionic gonadotropin(β-hCG) level (>10 mIU/ml) divided by number of embryo transfers
Time Frame
4th weeks after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI 18~23 kg/m2
Women with moderate to severe IUA as defined by the American Fertility Society classification (1988)
Presence of at least 3 cryopreserved cleavage-stage embryos (including 1 good quality) or blastocysts
Exclusion Criteria:
Using embryos from donor oocytes
Preimplantation genetic diagnosis(PGD)/Preimplantation genetic screening(PGS) cycles
Moderate or severe endometriosis
Untreated unilateral or bilateral hydrosalpinx
Uterine adenomyosis, uterine myoma (submucous,intramural myoma >4 cm),>1cm septate uterus, double uterus, bicornuate uterus, unicornuate uterus
Facility Information:
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
12. IPD Sharing Statement
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HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients
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