FSH Followed by HMG vs FSH Plus HMG in IVF

IVF Clinical Trial

Official title:

Follicle Stimulating Hormone (FSH) Followed by Human Menopausal Gonadotropin (HMG) Versus FSH Plus HMG During Controlled Ovarian Stimulation for in Vitro Fertilization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385342
• Other study ID #: R.20.04.823
• Status: Recruiting
• Phase: Phase 4
• Start date: June 30, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: June 2020
• Source: Mansoura University
• Contact: Ahmed Gibreel, MD
• Phone: 01221191133
• Email: ahmedfathgi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: August 31, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

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.

Related Conditions & MeSH terms

• IVF

Intervention

Drug:
• FSH
Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG
• HP-hMG
Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG

Locations

Country	Name	City	State
Egypt	Department of Obstetrics and Gynecology	Alexandria
Egypt	Fertility Care Unit (FCU) in Mansoura University Hospital	Mansourah	Dakahlia
Egypt	RAHEM Fertility Centre	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Number of ongoing pregnancies (defined as pregnancies passed beyond 12 weeks gestational age) divided by the number of women randomized	12 weeks gestational age
Secondary	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 women randomized	6 weeks after embryo transfer
Secondary	Implantation rate	Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos	6 weeks after embryo transfer
Secondary	Miscarriage rate	Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies	12 weeks gestational age