Clinical trial NCT01606709: Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
Official title: A Prospective Comparison of Transcriptional Profiling of Luteal Phase Endometrial Biopsies After Induction of Oocyte Maturation With a Gonadotropin Releasing Hormone (GnRH) Agonist or Human Chorionic Gonadotropins (hCG)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Endometrial Receptivity
Ovarian Hyperstimulation Syndrome
Keywords: GnRHa trigger
endometrial gene profile
quality of life
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2012-05-28
Enrollment: 7
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endometrial Gene Expression Profile
timeFrame: 7 days after trigger of oocyte maturation
Secondary outcomes:
measure: Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger
timeFrame: At baseline and up to 7 days after trigger of oocyte maturation
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UCHC Division of Reproductive Endocrinology
state: Connecticut
Study officials:
affiliation: UConn Health
name: Lawrence Engmann, MD, MRCOG
role: PRINCIPAL_INVESTIGATOR
References: