Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation

NCTNCT01606709Other id11-168-1

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Difficult to recruit patients

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 7 participants (actual)
Sponsor: UConn Health · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: Apr 2012
Primary completion: Dec 2014
Completion: Dec 2014
First posted: 28 May 2012 (estimated)
Last update posted: 21 Nov 2018
Conditions: Endometrial Receptivity · Ovarian Hyperstimulation Syndrome

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201320142015

Ph 4
Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
NCT01606709
Apr 2012 to Dec 2014
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to compare gene expression profiles in endometrial biopsies during the window of implantation after triggers of oocyte maturation using GnRH agonist or hCG and compared with their natural cycles in order to identify genes that may be dysregulated in GnRH agonist-triggered cycles. The investigators also intend to evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

Interventions

GnRH agonistDrug
hCGDrug

Arms2

Experimental
GnRH agonist trigger
Induction of oocyte maturation with GnRH agonist
Active comparator
hCG trigger
Induction of oocyte maturation with hCG

Primary outcomes1

Outcomes the sponsor listed as primary.

Endometrial Gene Expression Profile
Time frame · 7 days after trigger of oocyte maturation
Registry description
Microarray of gene expression in the midluteal phase

Secondary outcomes(1)

Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger
Time frame · At baseline and up to 7 days after trigger of oocyte maturation

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 7 days after trigger of oocyte maturation

Endometrial Gene Expression Profile

Group	Value
GnRH Agonist Trigger	not posted
hCG Trigger	not posted

Secondary and other outcome results(1)

Secondary outcome· At baseline and up to 7 days after trigger of oocyte maturation

Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger

Group	Value
GnRH Agonist Trigger	not posted
hCG Trigger	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GnRH Agonist TriggerInduction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose	0 / 4	0 / 4	0 / 4
hCG TriggerInduction of oocyte maturation with hCG hCG: 5,000 IU one dose	0 / 3	0 / 3	0 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 21 Years up to 33 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Oocyte donors * Ages between 21 and 33 * Normal baseline serum FSH \< 10mIU/mL Exclusion Criteria: * Hypothalamic dysfunction * Smokers * Baseline serum FSH ≥ 10mIU/mL

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