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

NCT02273791 | Completed

• 1 other identifier: MSA1
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 2

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)

Conditions

Infertility; Polycystic Ovarian Syndrome

Keywords

Frozen-thawed embryo transfer; FET protocols

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  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

  6 weeks after embryo transfer

Secondary Outcomes (2)

• Implantation rate

  6 weeks after embryo transfer

• Miscarriage rate

  12 weeks gestational age

Study Arms (2)

HRT group

Women will be subjected to HRT using Estradiol valerate before FET

Drug: Estradiol valerate

MOS group

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

Drug: Sequential Clomiphene citrate and Gonadotropin

Interventions

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.

Also known as: Cycloprogynova (white tablets)

HRT group

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.

Also known as: Sequential Clomid and Menogon

MOS group

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Fertility Care Unit (FCU) in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

Private fertility care centers

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Infertility; Polycystic Ovary Syndrome

Interventions

Estradiol; Gonadotropins; Menotropins

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Gonadotropins, Pituitary; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Officials

• Mohamed S Abdelhafez, Dr

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Mohamed I Eid, Dr

  Mansoura University

  STUDY DIRECTOR

• Mahmoud M Abdelrazik, Dr

  Mansoura University

  STUDY DIRECTOR

• Maher S Elsegaey, Dr

  Mansoura University

  STUDY DIRECTOR

• Ahmed Badawy, Prof

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 19, 2014
• First Posted: October 24, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

EG (2)