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

Phase 4

Terminated

• Conditions: Endometrial Receptivity; Ovarian Hyperstimulation Syndrome
• Interventions: Drug: GnRH agonist; Drug: hCG

• Registration Number: NCT01606709
• Lead Sponsor: UConn Health

Brief Summary

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.

Detailed Description

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation (COH) which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. The use of a GnRH agonist for induction of final oocyte maturation in ovarian stimulation cycles utilizing GnRH antagonist for pituitary suppression has proven to be an effective method of preventing the risk of OHSS development.

Unfortunately, some studies, but not all, have also reported lower pregnancy rates in these cycles as compared to cycles using hCG trigger and this has been attributed to possible impaired endometrial receptivity.

The investigators intend to obtain endometrial biopsies collected from the same subject in a natural cycle and then a biopsy during either a GnRH agonist or hCG triggered stimulation. Expression profiles of mRNAs will first be screened using microarray technology. Relative levels of specific mRNAs that display altered expression in the GnRH-triggered samples, as assayed by microarray, will then be confirmed by real-time, quantitative reverse transcription/polymerase chain reaction (Q-PCR). The investigators shall also evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-19
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2017-04-17
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-22
• Last Update Submitted: 2018-10-22
• Results First Posted: 2018-11-21
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH agonist trigger	GnRH agonist	Induction of oocyte maturation with GnRH agonist
hCG trigger	hCG	Induction of oocyte maturation with hCG

Primary Outcome Measures

Name	Time	Method
Endometrial Gene Expression Profile	7 days after trigger of oocyte maturation	Microarray of gene expression in the midluteal phase

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCHC Division of Reproductive Endocrinology; 🇺🇸 Farmington, Connecticut, United States