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Difficult to recruit patients
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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH agonist trigger | Experimental | Induction of oocyte maturation with GnRH agonist |
|
| hCG trigger | Active Comparator | Induction of oocyte maturation with hCG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH agonist | Drug | GnRH agonist 1mg one dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial Gene Expression Profile | Microarray of gene expression in the midluteal phase | 7 days after trigger of oocyte maturation |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Engmann, MD, MRCOG | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHC Division of Reproductive Endocrinology | Farmington | Connecticut | 06030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GnRH Agonist Trigger | Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose |
| FG001 | hCG Trigger | Induction of oocyte maturation with hCG hCG: 5,000 IU one dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GnRH Agonist Trigger | Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose |
| BG001 | hCG Trigger | Induction of oocyte maturation with hCG hCG: 5,000 IU one dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endometrial Gene Expression Profile | Microarray of gene expression in the midluteal phase | Inadequate RNA quality to completely analyze gene expression | Posted | No | 7 days after trigger of oocyte maturation |
|
3 weeks for each patient
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GnRH Agonist Trigger | Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Engmann | UConnHealth | 8605258283 | lengmann@uchc.edu |
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| ID | Term |
|---|---|
| D016471 | Ovarian Hyperstimulation Syndrome |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D016729 | Leuprolide |
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| hCG | Drug | 5,000 IU one dose |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Secondary | Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger | Too few patients completed survey to meaningfully analyze data | Posted | At baseline and up to 7 days after trigger of oocyte maturation |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | hCG Trigger | Induction of oocyte maturation with hCG hCG: 5,000 IU one dose | 0 | 3 | 0 | 3 | 0 | 3 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D006062 | Gonadotropins |
| D010926 | Placental Hormones |
| D011257 | Pregnancy Proteins |