Ovarian Hyperstimulation SyndromePhase 4ERAMADNCT01500863
Endometrial Receptivity After GnRH Agonist Triggering
A Phase 4 study testing hCG, triptorelin and Triptorelin, estradiol valerate, micronized vaginal progesterone in people with Ovarian Hyperstimulation Syndrome, run by IVI Madrid at 1 site in Spain.
Trial summary
Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS) still occurs in 1-3% of the patients. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- hCG, triptorelin and Triptorelin, estradiol valerate, micronized vaginal progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2011to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy oocyte donor women
- Aged 18-35 years
- With a menstrual cycle length of 26-35 days
- Normal ultrasound scan of uterus and ovaries
- Normal basal hormones
- No contraindication for controlled ovarian stimulation (COS)
- Willing to participate in the study and providing written informed consent.
Who cannot join
- Subjects with current or previous history of an endocrine abnormality
- Subjects with an abnormal outcome of blood biochemistry or hematology
- Subjects with an abnormal cervical smear
- Subjects with a chronic disease
- Subjects with any relevant ovarian-, tubal- or uterine-pathology that could interfere with the COS treatment
- Pregnancy
Show all 11Show fewer
- Subjects who had a previous history of ovarian hyperresponse or ovarian hyperstimulation syndrome (OHSS), polycystic ovary syndrome (PCOS) or a basal antral follicle count (AFC) of more than 20 on ultrasound (11 mm, both ovaries combined) .
- Previous low ovarian response to FSH or hMG treatment (i.e. cycle cancelled due to insufficient ovarian response or less than 6 oocytes obtained).
- A history of recurrent miscarriage,
- Smoking more than 10 cigarettes per day.
- Not willing to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation
Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS) still occurs in 1-3% of the patients. If gonadotropin-releasing hormone agonist (GnRHa) are used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.
By testing different luteal support protocols on women undergoing GnRHa triggering, the investigators aim to find out which protocol resembles the most the gene expression profile observed after hCG triggering and conventional luteal phase support, in order to choose it as the most adequate in terms of endometrium receptivity and safety (OHSS incidence).
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- hCG, triptorelin, Triptorelin, estradiol valerate, micronized vaginal progesterone, triptorelin, hCG, triptorelin, recombinant LH
- Keywords
- endometrial receptivity, gene arrays, agonist triggering, Endometrial gene expression, OHSS
- 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.
hCGDrug
single shot of 6500 IU hCG s.c. at the time of triggering
triptorelinDrug
single shot of 0.2mg triptorelin s.c. at the time of triggering
Triptorelin, estradiol valerate, micronized vaginal progesteroneDrug
4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
triptorelin, hCGDrug
single shot of 1500 IU hCG s.c. the day of OPU plus 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
triptorelin, hCGDrug
Multiple doses of 500 IU hCG (OPU, +4 and +7) and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
triptorelin, recombinant LHDrug
300 IU recombinant LH every 48h and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
| Study group | Role | What they receive |
|---|---|---|
| hCG | Active comparator | Not described Receives: Drug: hCG |
| Triptorelin 0.2mg s.c. | Experimental | Not described Receives: Drug: triptorelin |
| 0.2mg triptorelin plus estradiol/progesterone | Experimental | Not described Receives: Drug: Triptorelin, estradiol valerate, micronized vaginal progesterone |
| 0.2mg tripoterlin plus single bolus hCG 1500 IU | Experimental | Not described Receives: Drug: triptorelin, hCG |
| 0.2mg tripoterlin plus multiple boluses hCG 500 IU | Experimental | Not described Receives: Drug: triptorelin, hCG |
| 0.2mg tripoterlin plus multiple doses recLH | Experimental | Not described Receives: Drug: triptorelin, recombinant LH |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial receptivity gene expression profile
Measured: participants will be followed for the duration of the cycle, an expected average of 4 weeks
Secondary outcomes (1)
Incidence of moderate/severe OHSS in all different treatment group
Mild OHSS Grade 1, abdominal distension and discomfort Grade 2, features of grade 1 plus nausea, vomiting and/or diarrhea; ovaries are enlarged from 5 to 12 cm Moderate OHSS Grade 3, features of mild OHSS plus ultrasonic evidence of ascites Severe OHSS Grade 4, features of moderate OHSS plus evidence of ascites and/or hydrothorax and breathing difficulties Grade 5, all of the above, plus change in the blood volume, increased blood viscosity due to hemoconcentration, coagulation abnormality, and diminished renal perfusion and function
Measured: participants will be followed for the duration of the cycle, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfonso Bermejo, MD, Study director, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500863
- Sponsor's protocol ID
- MAD-AB-ERA-2011
- Acronym
- ERAMAD
- Status last verified
- Oct 2016
- First submitted
- 20 Dec 2011
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation
- ClinicalTrials.gov ID
- NCT01500863
- Acronym / sponsor ID
- ERAMAD / MAD-AB-ERA-2011
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- endometrial receptivity, gene arrays, agonist triggering, Endometrial gene expression, OHSS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS) still occurs in 1-3% of the patients. If gonadotropin-releasing hormone agonist (GnRHa) are used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.
By testing different luteal support protocols on women undergoing GnRHa triggering, the investigators aim to find out which protocol resembles the most the gene expression profile observed after hCG triggering and conventional luteal phase support, in order to choose it as the most adequate in terms of endometrium receptivity and safety (OHSS incidence).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| hCG | Active comparator | Drug: hCG |
| Triptorelin 0.2mg s.c. | Experimental | Drug: triptorelin |
| 0.2mg triptorelin plus estradiol/progesterone | Experimental | Drug: Triptorelin, estradiol valerate, micronized vaginal progesterone |
| 0.2mg tripoterlin plus single bolus hCG 1500 IU | Experimental | Drug: triptorelin, hCG |
| 0.2mg tripoterlin plus multiple boluses hCG 500 IU | Experimental | Drug: triptorelin, hCG |
| 0.2mg tripoterlin plus multiple doses recLH | Experimental | Drug: triptorelin, recombinant LH |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy oocyte donor women
- Aged 18-35 years
- With a menstrual cycle length of 26-35 days
- Normal ultrasound scan of uterus and ovaries
- Normal basal hormones
Key exclusion criteria (11 listed)
- Subjects with current or previous history of an endocrine abnormality
- Subjects with an abnormal outcome of blood biochemistry or hematology
- Subjects with an abnormal cervical smear
- Subjects with a chronic disease
- Subjects with any relevant ovarian-, tubal- or uterine-pathology that could interfere with the COS treatment
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 |
|---|---|---|
| hCGsingle shot of 6500 IU hCG s.c. at the time of triggering | Drug | hCG |
| triptorelinsingle shot of 0.2mg triptorelin s.c. at the time of triggering | Drug | Triptorelin 0.2mg s.c. |
| Triptorelin, estradiol valerate, micronized vaginal progesterone4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU | Drug | 0.2mg triptorelin plus estradiol/progesterone |
| triptorelin, hCGsingle shot of 1500 IU hCG s.c. the day of OPU plus 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU | Drug | 0.2mg tripoterlin plus single bolus hCG 1500 IU |
| triptorelin, hCGMultiple doses of 500 IU hCG (OPU, +4 and +7) and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU | Drug | 0.2mg tripoterlin plus multiple boluses hCG 500 IU |
| triptorelin, recombinant LH300 IU recombinant LH every 48h and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU | Drug | 0.2mg tripoterlin plus multiple doses recLH |
Primary outcome
endometrial receptivity gene expression profile
Time frame: participants will be followed for the duration of the cycle, an expected average of 4 weeks
1 secondary outcome
Incidence of moderate/severe OHSS in all different treatment group
Time frame: participants will be followed for the duration of the cycle, an expected average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Ovarian Hyperstimulation Syndrome
RecruitingPhase 2
Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
Gynecologic Disease
RecruitingObservational study
Real-world Evidence on Follitropin Delta Individual Dosing
Infertility, Sterility
Recruiting
Ovarian Hyperstimulation Syndrome Prevention
Ovarian Hyper Stimulation Syndrome (OHSS)
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.
Alfonso Bermejo, MD study director
IVI Madrid
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 hCG, triptorelin and Triptorelin, estradiol valerate, micronized vaginal progesterone in people with Ovarian Hyperstimulation Syndrome, run by IVI Madrid at 1 site in Spain.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 26 Oct 2016. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 receptivity gene expression profile (time frame: participants will be followed for the duration of the cycle, an expected average of 4 weeks). 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 26 Oct 2016.