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GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Triptorelin
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring Luteal phase support, ICSI, GnRHa

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Fertility Care Unit (FCU) in Mansoura University HospitalRecruiting
  • Private fertility care centersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

GnRHa group

Control group

Arm Description

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

No GnRHa administration in luteal phase

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Implantation rate
Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos
Miscarriage rate
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

Full Information

First Posted
December 5, 2014
Last Updated
April 24, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02312089
Brief Title
GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles
Official Title
Gonadotropin Releasing Hormone Agonist for Luteal Phase Support in Gonadotropin Releasing Hormone Antagonist Protocol Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 GnRH antagonist protocol
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Luteal phase support, ICSI, GnRHa

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GnRHa group
Arm Type
Active Comparator
Arm Description
Luteal phase SC administration of a single dose (0.2 mg) of GnRHa (Triptorelin)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No GnRHa administration in luteal phase
Intervention Type
Drug
Intervention Name(s)
Triptorelin
Other Intervention Name(s)
Decapeptyl
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
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 Outcome Measure Information:
Title
Implantation rate
Description
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
Title
Miscarriage rate
Description
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Time Frame
12 weeks gestational age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed S Abdelhafez, Dr
Phone
+201144523366
Email
msabdelhafez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waleed El-refaie, Dr
Organizational Affiliation
Port Said University
Official's Role
Study Director
Facility Information:
Facility Name
Fertility Care Unit (FCU) in Mansoura University Hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Phone
+201144523366
Email
msabdelhafez@gmail.com
Facility Name
Private fertility care centers
City
Mansourah
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

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