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GnRH for Luteal Support in IVF/ICSI/FET Cycles

U

University Reproductive Associates

Status and phase

Enrolling
Phase 4

Conditions

Infertility

Treatments

Drug: placebo
Drug: GnRH

Study type

Interventional

Funder types

Other

Identifiers

NCT02357654
PRO20140001128

Details and patient eligibility

About

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 .

Full description

see above

Enrollment

350 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • day 3 transfers

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

350 participants in 2 patient groups, including a placebo group

GnRH agonist
Experimental group
Treatment:
Drug: GnRH
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Peter G McGovern, MD

Data sourced from clinicaltrials.gov

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