GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

Phase 4UnknownNCT02312089

Mansoura University200 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

200

Conditions

Infertility

Interventions

TriptorelinDRUG

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 38 Years

Medical Language ↔ Plain English

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.

Locations (2)

Fertility Care Unit (FCU) in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

Private fertility care centers

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 6 weeks after embryo transfer

Secondary Outcomes

Implantation rate

Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos

Time frame: 6 weeks after embryo transfer

Miscarriage rate

Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

Time frame: 12 weeks gestational age

Central Contacts

Mohamed S Abdelhafez, Dr

CONTACT

+201144523366 msabdelhafez@gmail.com

Data from ClinicalTrials.gov

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