GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

NCT ID: NCT02312089

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-07

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GnRHa group

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

Group Type ACTIVE_COMPARATOR

Triptorelin

Intervention Type DRUG

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

Control group

No GnRHa administration in luteal phase

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Decapeptyl

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Sayed Abdelhafez

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed S Abdelhafez, Dr

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Waleed El-refaie, Dr

Role: STUDY_DIRECTOR

Port Said University

Locations

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Fertility Care Unit (FCU) in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Private fertility care centers

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed S Abdelhafez, Dr

Role: CONTACT

+201144523366

Facility Contacts

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Mohamed S Abdelhafez, Dr

Role: primary

+201144523366

Other Identifiers

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MSA4

Identifier Type: -

Identifier Source: org_study_id

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