Endometrial ReceptivityPhase 4NCT01606709
Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
A Phase 4 study testing GnRH agonist and hCG in people with Endometrial Receptivity and Ovarian Hyperstimulation Syndrome, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 33 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Receptivity, Ovarian Hyperstimulation Syndrome
- What is being tested?
- GnRH agonist and hCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 33 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Oocyte donors
- Ages between 21 and 33
- Normal baseline serum FSH < 10mIU/mL
Who cannot join
- Hypothalamic dysfunction
- Smokers
- Baseline serum FSH ≥ 10mIU/mL
Trial locations and contacts
1 site in 1 country.
United States1 site
UCHC Division of Reproductive Endocrinology
Farmington, Connecticut, 06030
About this study
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)
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.
Read the 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.
- Being tested
- GnRH agonist, hCG
- Keywords
- GnRHa trigger, endometrial gene profile, quality of life
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH agonistDrug
Also called leuprolide acetate,, lupron
GnRH agonist 1mg one dose
hCGDrug
Also called Pregnyl
5,000 IU one dose
| Study group | Role | What they receive |
|---|---|---|
| GnRH agonist trigger | Experimental | Induction of oocyte maturation with GnRH agonist Receives: Drug: GnRH agonist |
| hCG trigger | Active comparator | Induction of oocyte maturation with hCG Receives: Drug: hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Gene Expression Profile
Microarray of gene expression in the midluteal phase
Measured: 7 days after trigger of oocyte maturation
Secondary outcomes (1)
Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger
Measured: At baseline and up to 7 days after trigger of oocyte maturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Difficult to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial ReceptivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Principal investigator, Lawrence Engmann, UConn Health
- Investigators
- Lawrence Engmann, MD, MRCOG, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606709
- Sponsor's protocol ID
- 11-168-1
- Status last verified
- Oct 2018
- First submitted
- 19 May 2012
- Last updated
- 21 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01606709
- Acronym / sponsor ID
- 11-168-1
- Keywords
- GnRHa trigger, endometrial gene profile, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult to recruit patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Apr 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 May 2012 (estimated)
- Results
- Posted 21 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH agonist trigger | Experimental | Drug: GnRH agonistInduction of oocyte maturation with GnRH agonist |
| hCG trigger | Active comparator | Drug: hCGInduction of oocyte maturation with hCG |
Who may qualify
- Ages
- 21 to 33 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Oocyte donors
- Ages between 21 and 33
- Normal baseline serum FSH < 10mIU/mL
Key exclusion criteria (3 listed)
- Hypothalamic dysfunction
- Smokers
- Baseline serum FSH ≥ 10mIU/mL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GnRH agonistAlso: leuprolide acetate,, lupronGnRH agonist 1mg one dose | Drug | GnRH agonist trigger |
| hCGAlso: Pregnyl5,000 IU one dose | Drug | hCG trigger |
Primary outcome
Endometrial Gene Expression Profile
Time frame: 7 days after trigger of oocyte maturation
Microarray of gene expression in the midluteal phase
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Engmann, MD, MRCOG principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GnRH agonist and hCG in people with Endometrial Receptivity and Ovarian Hyperstimulation Syndrome, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Gene Expression Profile (time frame: 7 days after trigger of oocyte maturation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.