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

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ClinicalTrials.gov Identifier: NCT02273791
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

Brief Summary:
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)

Condition or disease Intervention/treatment
Infertility Polycystic Ovarian Syndrome Drug: Estradiol valerate Drug: Sequential Clomiphene citrate and Gonadotropin

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.

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Polycystic Ovarian Syndrome Patients
Actual Study Start Date : December 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016


Group/Cohort Intervention/treatment
HRT group
Women will be subjected to HRT using Estradiol valerate before FET
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.
Other Name: Cycloprogynova (white tablets)

MOS group
Women will be subjected to MOS using sequential clomiphene citrate and gonadotropin before FET
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.
Other Name: Sequential Clomid and Menogon




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
FET cycles carried out for PCOS women who had previously undergone ICSI with cryopreservation of at least 2 good quality cleavage-stage embryos
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273791


Locations
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Egypt
Fertility Care Unit (FCU) in Mansoura University Hospital
Mansourah, Dakahlia, Egypt, 35111
Private fertility care centers
Mansourah, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mohamed S Abdelhafez, Dr Mansoura University
Study Director: Mohamed I Eid, Dr Mansoura University
Study Director: Mahmoud M Abdelrazik, Dr Mansoura University
Study Director: Maher S Elsegaey, Dr Mansoura University
Study Chair: Ahmed Badawy, Prof Mansoura University

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Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02273791    
Other Study ID Numbers: MSA1
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
Frozen-thawed embryo transfer
FET protocols
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Infertility
Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Clomiphene
Enclomiphene
Zuclomiphene
Estradiol
Polyestradiol phosphate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogens
Hormones