FSH Followed by HMG vs FSH Plus HMG in IVF

NCT ID: NCT04385342

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-08-31

Brief Summary

The aim of this study is to compare the clinical outcomes of sequential administration of FSH and HP-hMG FSH alone versus concomitant administration of FSH and HP-hMG during controlled ovarian stimulation in IVF cycles.

Detailed Description

Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol will be assessed for possibility of participation in our study. Eligible participants in our study will be those with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).

Women with any of the following criteria will be excluded from the study: 1) age < 20 or > 37 years; 2) body mass index (BMI) < 18 or > 25 kg/m2; 3) low ovarian reserve (AFC < 7 and/or AMH < 1.1 ng/ml); 4) presence of polycystic ovarian syndrome (PCOS), endometrioma or hydrosalpinx; 5) history of chemotherapy, radiotherapy or ovarian surgery; 6) the husband needs testicular biopsy to obtain sperm; or 7) previous implantation failure.

A written informed consent will be taken from each women selected to participate before inclusion in the study. All women participating in the study will start GnRHa on day 21 of the preceding cycle and when down regulation occurs each woman will be randomly allocated into one of the two groups; group 1 and group 2. Women in group 1 will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering. Women in group 2 will receive 150 IU FSH plus 75 IU HP-hMG from day one of ovarian stimulation and 150IU HP-HMG when the follicular diameters reaches 10-12 mm till day of triggering. The randomization will be simple and balanced (1:1) and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing computer-generated random numbers. The data assesor will be blinded to group assignment.

In both groups, estradiol and LH will be measured on the third day of menstruation before start of stimulation and on day 6 of stimulation TVS will be performed. Progesterone and E2 will be measured and on day of triggering. The primary outcome measure of this study will be the ongoing pregnancy rate. The secondary outcomes measures will be cancellation rate, the number of oocytes retrieved, the number of embryos, the number of vitrified embryos, the clinical pregnancy rate, the implantation rate, OHSS rate, multiple pregnancy rate, and the miscarriage rate.

Conditions

IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FSH then HP-hMG

Women will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering

Group Type: ACTIVE_COMPARATOR

FSH

Intervention Type: DRUG

Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG

HP-hMG

Intervention Type: DRUG

Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG

FSH + HP-hMG

Women will receive 150 IU FSH plus 75IU HP-hMG from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm 150 IU HP-HMG till day of triggering

Group Type: ACTIVE_COMPARATOR

FSH

Intervention Type: DRUG

Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG

HP-hMG

Intervention Type: DRUG

Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG

Interventions

FSH

Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG

Intervention Type: DRUG

HP-hMG

Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG

Intervention Type: DRUG

Other Intervention Names

Fostimon, Gonal-F, Puragon; Meriofert, Menopure

Eligibility Criteria

Inclusion Criteria

• Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol.
• Women with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).

Exclusion Criteria

• Age < 20 or > 37 years.
• Body mass index (BMI) < 18 or > 30 kg/m2.
• Low ovarian reserve (AFC < 7 and/or AMH < 1.1 ng/ml).
• Presence of polycystic ovarian syndrome (PCOS).
• Endometrioma or hydrosalpinx.
• History of chemotherapy, radiotherapy or ovarian surgery.
• The husband needs testicular biopsy to obtain sperm.
• Previous implantation failure.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Gibreel, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Mohamed S Abdelhafez, MD

Role: STUDY_DIRECTOR

Mansoura University

Hasan El Maghraby, MD

Role: STUDY_DIRECTOR

Alexandria University

Hamed Yossef, MD

Role: STUDY_CHAIR

Mansoura University

Locations

Fertility Care Unit (FCU) in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status: NOT_YET_RECRUITING

Department of Obstetrics and Gynecology

Alexandria, , Egypt

Site Status: RECRUITING

RAHEM Fertility Centre

Zagazig, , Egypt

Site Status: NOT_YET_RECRUITING

Countries

Egypt

Central Contacts

Ahmed Gibreel, MD

Role: CONTACT

ahmedfathgi@yahoo.com

01221191133

Facility Contacts

Hamed Yossef, MD

Role: primary

Hasan El Maghraby, MD

Role: primary

Eman Elgindy, PhD

Role: primary

eman_elgindy2013@hotmail.com

Other Identifiers

R.20.04.823

Identifier Type: -

Identifier Source: org_study_id