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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 38 Years
Gender	Female

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02330757
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mansoura University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mohamed S Abdelhafez, Dr
Principal Investigator Affiliation	Mansoura University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Infertility

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: HRT group

Women will be subjected to HRT using Estradiol valerate before FET

Active Comparator: MOS group

Women will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET

Interventions

Drug: - 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.

Drug: - 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.

Contact a Trial Team

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International Sites

Mansourah, Dakahlia, Egypt

Status

Recruiting

Address

Fertility Care Unit (FCU) in Mansoura University Hospital

Mansourah, Dakahlia, 35111

Site Contact

Mohamed S Abdelhafez, Dr

[email protected]

+201144523366

Private fertility care centers, Mansourah, Dakahlia, Egypt

Status

Recruiting

Address

Private fertility care centers

Mansourah, Dakahlia,

Site Contact

[email protected]

+201144523366

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