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

NCT01606709 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 11-168-1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Receptivity; Ovarian Hyperstimulation Syndrome

Keywords

GnRHa trigger; endometrial gene profile; quality of life

Outcome Measures

Primary Outcomes (1)

• Endometrial Gene Expression Profile

  Microarray of gene expression in the midluteal phase

  7 days after trigger of oocyte maturation

Secondary Outcomes (1)

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

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

Study Arms (2)

GnRH agonist trigger

EXPERIMENTAL

Induction of oocyte maturation with GnRH agonist

Drug: GnRH agonist

hCG trigger

ACTIVE COMPARATOR

Induction of oocyte maturation with hCG

Drug: hCG

Interventions

GnRH agonist DRUG

GnRH agonist 1mg one dose

Also known as: leuprolide acetate,, lupron

GnRH agonist trigger

hCG DRUG

5,000 IU one dose

Also known as: Pregnyl

hCG trigger

Eligibility Criteria

• Age: 21 Years - 33 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Oocyte donors
• Ages between 21 and 33
• Normal baseline serum FSH \< 10mIU/mL

You may not qualify if:

• Hypothalamic dysfunction
• Smokers
• Baseline serum FSH ≥ 10mIU/mL

Sponsors & Collaborators

• UConn Health: lead
• Schering-Plough: collaborator

Study Sites (1)

UCHC Division of Reproductive Endocrinology

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Gonadotropin-Releasing Hormone; Leuprolide; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropins; Placental Hormones; Pregnancy Proteins

Results Point of Contact

• Title: Lawrence Engmann
• Organization: UConnHealth

lengmann@uchc.edu

8605258283

Study Officials

• Lawrence Engmann, MD, MRCOG

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 19, 2012
• First Posted: May 28, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 21, 2018
• Results First Posted: November 21, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)