HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Infertility, Female, Intrauterine Adhesion

Intervention / Treatment
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* Drug: human menopausal gonadotrophin
* Drug: hormone replacement therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental-HMG stimulation group<br>Women will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer | Drug: human menopausal gonadotrophin<br>* 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.<br>|
| Active Comparator: Control-HRT group<br>Women will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer | Drug: hormone replacement therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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） | 10th week after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycle cancellation rate |  | the day of embryo transfer | 
| Implantation rate | Sacs seen in early ultrasound divided by the number of embryos transferred | 4th weeks after embryo transfer | 
| Clinical pregnancy rate | Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers | 4th weeks after embryo transfer | 
| Early miscarriage rate | Number of losses of clinical pregnancies divided by number of clinical pregnancies | 12th weeks gestational age | 
| 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 | 4th weeks after embryo transfer |