HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients
NCT ID: NCT03578172
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
186 participants
INTERVENTIONAL
2018-07-18
2019-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental-HMG stimulation group
Women will be subjected to ovarian stimulation for endometrial preparation using human menopausal gonadotrophin before blastocyst transfer
human menopausal gonadotrophin
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.
Control-HRT group
Women will be subjected to hormone replacement therapy for endometrial preparation before blastocyst transfer
hormone replacement therapy
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.
Interventions
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human menopausal gonadotrophin
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.
hormone replacement therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
35 Years
FEMALE
No
Sponsors
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Reproductive & Genetic Hospital of CITIC-Xiangya
OTHER
Responsible Party
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Locations
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Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, China
Countries
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Other Identifiers
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KYXM-2018001
Identifier Type: -
Identifier Source: org_study_id
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