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

NCT02330757 | Unknown Phase 4

• 1 other identifier: MSA2
• Study Type: interventional
• Target: 150
• 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 without polycystic ovarian syndrome (PCOS)

Conditions

Infertility

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

ACTIVE COMPARATOR

Women will be subjected to HRT using Estradiol valerate before FET

Drug: Estradiol valerate

MOS group

ACTIVE COMPARATOR

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)

You may qualify if:

• 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).

You may not qualify if:

• PCOS or polycystic ovary on ultrasound scan.
• 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

RECRUITING

Private fertility care centers

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Estradiol; Gonadotropins; Menotropins

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital 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

Central Study Contacts

Mohamed S Abdelhafez, Dr

CONTACT

+201144523366; msabdelhafez@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: January 5, 2015
• Study Start: October 10, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

EG (2)