HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients

Phase 4

Recruiting

• Conditions: Infertility
• Interventions: Drug: Sequential Clomiphene citrate and Gonadotropin; Drug: Estradiol valerate

• Registration Number: NCT02330757
• Lead Sponsor: Mansoura University

Brief Summary

Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome (PCOS)

Detailed Description

Women will be randomly divided into two groups; one will be subjected to endometrial preparation by hormone replacement therapy (HRT) and the other will be subjected to minimal ovarian stimulation (MOS). Women in the HRT group 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. Women in the MOS group 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. In both groups, FET will be planned in the appropriate day according to the stage that the embryos have been cryopreserved in it.

Study Timeline

• Study First Submitted: 2015-01-01
• Study First Submitted QC: 2015-01-01
• Study First Posted: 2015-01-05
• Study Start: 2016-10-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Women without PCOS as defined by the Rotterdam 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

• PCOS or polycystic ovary on ultrasound scan.
• Moderate or severe endometriosis.
• Hydrosalpinx.
• Uterine abnormalities or myoma.
• Previous uterine surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOS group	Sequential Clomiphene citrate and Gonadotropin	Women will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET
HRT group	Estradiol valerate	Women will be subjected to HRT using Estradiol valerate before FET

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6 weeks after embryo transfer	Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures

Secondary Outcome Measures

Name	Time	Method
Miscarriage rate	12 weeks gestational age	Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Implantation rate	6 weeks after embryo transfer	Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos

Trial Locations

Locations (2)

Fertility Care Unit (FCU) in Mansoura University Hospital; 🇪🇬 Mansourah, Dakahlia, Egypt

Private fertility care centers; 🇪🇬 Mansourah, Dakahlia, Egypt