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Active, not recruitingNCT02357654Updated Oct 19, 2026

GnRH for Luteal Support in IVF/ICSI/FET Cycles

A Phase 4 interventional study of GnRH and placebo in Infertility, sponsored by University Reproductive Associates. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by University Reproductive Associates · Phase 4, Interventional, and Treatment

Updated Oct 19, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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 .

Read the detailed description

see above

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 350 is above the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

University Reproductive Associates is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • day 3 transfers
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
350 participants (estimated)

Study arms

  • Experimental
    GnRH agonist

    Drug: GnRH

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • DrugGnRH

    single shot of GnRH agonist

  • Drugplacebo

    placebo

06

What researchers measure

Primary outcomes

  1. Live birth per transfer

    Time frame: 9 months

Secondary outcomes

  1. implantation rates

    Time frame: 4 weeks

  2. clinical pregnancy

    Time frame: 4 weeks

  3. rates of OHSS

    Time frame: 4 weeks

07

Study locations

1 site
  • University Reproductive Associates
    Hasbrouck Heights, New Jersey 07604, United States
08

References and documents

Publications

  • 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. PubMed 21975790 ↗
  • 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. PubMed 20825643 ↗
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2015 (actual). Primary completion is estimated for Jul 2027, 140 months after the start.

Of 73 non-industry phase 4 interventional studies under Infertility, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 82. This study's planned 140 months is above that.

Counting every sponsor, half of 80 studies reached it within 33 months; a quarter within 19 and three quarters within 82.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: primary completion Jul 2026 → Jul 2027 and completion Jul 2026 → Nov 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2015
First posted
Feb 6, 2015
StartActual
Nov 2015
Primary completionEst.
Jul 2027was Jul 2026
CompletionEst.
Nov 2027was Jul 2026
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 19, 2026
Primary completion
Jul 2026→Jul 2027
Oct 19, 2026
Study completion
Jul 2026→Nov 2027
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Recruiting→Active, not recruiting
    Primary completion Jul 2026→Jul 2027
    Study completion Jul 2026→Nov 2027
    + 4 other changes: documents, verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02357654
Lead sponsor
University Reproductive Associates
Responsible party
Sponsor
First posted
Feb 6, 2015
Start date
Nov 2015
Primary completion
Jul 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Oct 19, 2026

Study contacts

Peter G McGovern, MD
principal investigator · Rutgers University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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