Endometrial Receptivity, Ovarian Hyperstimulation Syndrome
Conditions
Keywords
GnRHa trigger, endometrial gene profile, quality of life
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.
Interventions
DRUGGnRH agonist
GnRH agonist 1mg one dose
DRUGhCG
5,000 IU one dose
Sponsors
Schering-Plough
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 33 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial Gene Expression Profile | 7 days after trigger of oocyte maturation | Microarray of gene expression in the midluteal phase |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger | At baseline and up to 7 days after trigger of oocyte maturation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GnRH Agonist Trigger Induction of oocyte maturation with GnRH agonist
GnRH agonist: GnRH agonist 1mg one dose | 4 |
| hCG Trigger Induction of oocyte maturation with hCG
hCG: 5,000 IU one dose | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | GnRH Agonist Trigger | hCG Trigger | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 3 Participants | 7 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
Endometrial Gene Expression Profile
Microarray of gene expression in the midluteal phase
Time frame: 7 days after trigger of oocyte maturation
Population: Inadequate RNA quality to completely analyze gene expression
Secondary
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
Population: Too few patients completed survey to meaningfully analyze data