HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients
NCT ID: NCT02330757
Last Updated: 2023-10-30
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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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2016-10-10
2024-12-31
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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HRT group
Women will be subjected to HRT using Estradiol valerate before FET
Estradiol valerate
Women will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is \< 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started.
MOS group
Women will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET
Sequential Clomiphene citrate and Gonadotropin
Women will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle \> 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours.
Interventions
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Estradiol valerate
Women will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is \< 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started.
Sequential Clomiphene citrate and Gonadotropin
Women will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle \> 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).
Exclusion Criteria
* Moderate or severe endometriosis.
* Hydrosalpinx.
* Uterine abnormalities or myoma.
* Previous uterine surgery.
20 Years
38 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Mohamed Sayed Abdelhafez
Dr
Principal Investigators
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Mohamed S Abdelhafez, Dr
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Locations
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Fertility Care Unit (FCU) in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Private fertility care centers
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MSA2
Identifier Type: -
Identifier Source: org_study_id
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