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GnRH for Luteal Support in IVF/ICSI/FET Cycles

Primary Purpose

Infertility

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
GnRH
placebo
Sponsored by
University Reproductive Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women undergoing IVF/ICSI or frozen embryo transfers (FET) that less than 40 years old.

Exclusion Criteria:

  • day 3 transfers

Sites / Locations

  • University Reproductive AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GnRH agonist

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Live birth per transfer

Secondary Outcome Measures

implantation rates
clinical pregnancy
rates of OHSS

Full Information

First Posted
January 7, 2015
Last Updated
May 10, 2023
Sponsor
University Reproductive Associates
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1. Study Identification

Unique Protocol Identification Number
NCT02357654
Brief Title
GnRH for Luteal Support in IVF/ICSI/FET Cycles
Official Title
GnRH for Luteal Support in IVF/ICSI/FET Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Reproductive Associates

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days after fertilization. For a successful pregnancy to take place, that embryo must then implant in the properly primed and staged endometrium, which subsequently must continue to develop to accommodate the growing and maturing embryo and then fetus. This process is normally regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has been found that after IVF additional support for the endometrium with progesterone improves implantation and subsequent live birth rates in IVF cycle . Recent data has shown that additional supplementation with a single administration of a GnRH agonist around the time the time of embryo transfer may further enhance these rates .
Detailed Description
see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GnRH agonist
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GnRH
Intervention Description
single shot of GnRH agonist
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Live birth per transfer
Time Frame
9 months
Secondary Outcome Measure Information:
Title
implantation rates
Time Frame
4 weeks
Title
clinical pregnancy
Time Frame
4 weeks
Title
rates of OHSS
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women undergoing IVF/ICSI or frozen embryo transfers (FET) that less than 40 years old. Exclusion Criteria: day 3 transfers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter G McGovern, MD
Phone
201-288-6330
Email
mcgovepg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter G McGovern, MD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Reproductive Associates
City
Hasbrouck Heights
State/Province
New Jersey
ZIP/Postal Code
07604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter G. McGovern, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21975790
Citation
van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD009154. doi: 10.1002/14651858.CD009154.pub2.
Results Reference
background
PubMed Identifier
20825643
Citation
Oliveira JB, Baruffi R, Petersen CG, Mauri AL, Cavagna M, Franco JG Jr. Administration of single-dose GnRH agonist in the luteal phase in ICSI cycles: a meta-analysis. Reprod Biol Endocrinol. 2010 Sep 8;8:107. doi: 10.1186/1477-7827-8-107.
Results Reference
background

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GnRH for Luteal Support in IVF/ICSI/FET Cycles

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