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Completed

NCT Number: NCT02273791

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

Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients with polycystic ovarian syndrome (PCOS)

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Key information

Age range

20 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

Fertility Care Unit (FCU) in Mansoura University Hospital, Al Mansurah, Dakahlia Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with 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

  • Moderate or severe endometriosis.
  • Hydrosalpinx.
  • Uterine abnormalities or myoma.
  • Previous uterine surgery.

Treatment and study plan

estradiol valerate

Drug

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.

Other names: Cycloprogynova (white tablets)

Sequential Clomiphene citrate and Gonadotropin

Drug

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 names: Sequential Clomid and Menogon

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 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 outcomes

  1. Implantation rate

    Time frame: 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

  2. Miscarriage rate

    Time frame: 12 weeks gestational age

    Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Polycystic Ovarian Syndrome Patients

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2014
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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