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GnRH for Luteal Support in IVF/ICSI/FET Cycles

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ClinicalTrials.gov Identifier: NCT02357654
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
University Reproductive Associates

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 .

Condition or disease Intervention/treatment Phase
Infertility Drug: GnRH Drug: placebo Phase 4

Detailed Description:
see above

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GnRH for Luteal Support in IVF/ICSI/FET Cycles
Study Start Date : November 2015
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: GnRH agonist Drug: GnRH
single shot of GnRH agonist

Placebo Comparator: Placebo Drug: placebo
placebo




Primary Outcome Measures :
  1. Live birth per transfer [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. implantation rates [ Time Frame: 4 weeks ]
  2. clinical pregnancy [ Time Frame: 4 weeks ]
  3. rates of OHSS [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • day 3 transfers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357654


Contacts
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Contact: Peter G McGovern, MD 201-288-6330 mcgovepg@gmail.com

Locations
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United States, New Jersey
University Reproductive Associates Recruiting
Hasbrouck Heights, New Jersey, United States, 07604
Principal Investigator: Peter G. McGovern, MD         
Sponsors and Collaborators
University Reproductive Associates
Investigators
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Principal Investigator: Peter G McGovern, MD Rutgers University
Publications:
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Responsible Party: University Reproductive Associates
ClinicalTrials.gov Identifier: NCT02357654    
Other Study ID Numbers: PRO20140001128
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Infertility