GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles

Infertility Clinical Trial

Official title:

Gonadotropin Releasing Hormone Agonist for Luteal Phase Support in Long Gonadotropin Releasing Hormone Agonist Protocol Cycles

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02312076
• Other study ID #: MSA3
• Status: Recruiting
• Phase: Phase 4
• Start date: September 9, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: Mohamed S Abdelhafez, Dr
• Phone: +201144523366
• Email: msabdelhafez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following long GnRHa protocol

Description:

Endometrial preparation for embryo transfer (ET) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. The patients will be randomly divided into 2 groups for luteal phase support: (i) Group A (GnRHa group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval, and (ii) Group B (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after ET

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

Inclusion Criteria:

• Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRHa.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Triptorelin
Luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval

Locations

Country	Name	City	State
Egypt	Fertility Care Unit (FCU) in Mansoura University Hospital	Mansourah	Dakahlia
Egypt	Private fertility care centers	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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