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

M

Mansoura University

Status

Completed

Conditions

Infertility
Polycystic Ovarian Syndrome

Treatments

Drug: Estradiol valerate
Drug: Sequential Clomiphene citrate and Gonadotropin

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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)

Full 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.

Enrollment

126 patients

Sex

Female

Ages

20 to 38 years old

Volunteers

No Healthy Volunteers

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.

Trial design

126 participants in 2 patient groups

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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