GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

Mansoura University

Status and phase: Enrolling; Phase 4

Conditions: Infertility

Treatments: Drug: Triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT02312089

MSA4

Details and patient eligibility

About

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 GnRH antagonist protocol

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

GnRHa group

Active Comparator group

Description:

Luteal phase SC administration of a single dose (0.2 mg) of GnRHa (Triptorelin)

Treatment:

Drug: Triptorelin

Control group

No Intervention group

Description:

No GnRHa administration in luteal phase