Women With Poor Ovarian ResponseNCT02144818
GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian Response
A study testing Ovitrel and Decapeptyl in people with Women With Poor Ovarian Response, run by Sheba Medical Center at 1 site in Israel.
Trial summary
During the last decades, owing to the growing tendency of women to delay childbearing plans because of career and personal priorities, fertility specialists today are seeing more and more women with poor ovarian reserve and with poor ovarian response Controlled ovarian hyperstimulation (COH) is considered a important… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women With Poor Ovarian Response
- What is being tested?
- Ovitrel and Decapeptyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jul 2015
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.
Who cannot join
- Women with good ovarian response.
- Women with low ovarian response who are carriers of fragile X
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center
Ramat Gan
Jigal Haas, M.D, 0972524651054, jigalh@hotmail.com
Jigal Haas, M.D
About this study
Official title: GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian
During the last decades, owing to the growing tendency of women to delay childbearing plans because of career and personal priorities, fertility specialists today are seeing more and more women with poor ovarian reserve and with poor ovarian response Controlled ovarian hyperstimulation (COH) is considered a important factor in the success of in vitro fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and, thereby, resulting in more than one embryo. However, owing to the extreme variability in ovarian response to COH, in a subgroup of patients with poor ovarian response, this method may yield a very small number of follicles After succeeding in maximal recruitment of the follicles, the triggering of ovulation is extremely important in order to achieve, as many as, mature oocytes.
Several studies have reported retrieval of more mature oocytes after GnRH agonist triggering compared to the number of oocytes retrieved after hCG. Among the possible advantages of GnRH agonist for final oocyte maturation is the simultaneous induction of an FSH surge. The role of the natural mid-cycle FSH surge is not fully clear. FSH was reported to induce LH receptor formation in luteinizing granulosa cells, and to promote oocyte nuclear maturation and cumulus expansion .
Read more
Another method described to trigger ovulation is the "Dual triggering"- GnRH agonist 40 h prior to ovum pickup and hCG added 6 h after the first trigger. The dual triggering was described as the treatment in cases with recurrent empty follicles.
The aim of the present study is to evaluate three different methods of ovulation triggering in women with poor ovarian response
Read the detailed description
Inclusion criteria:
- Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.
Exclusion criteria:
- Women with good ovarian response.
- Women with low ovarian response who are carriers of fragile X
- Conditions
- Women With Poor Ovarian Response
- Being tested
- Ovitrel, Decapeptyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OvitrelDrug
Triggering of ovulation with Ovitrel
DecapeptylDrug
Triggering with GnRH agonist
| Study group | Role | What they receive |
|---|---|---|
| GnRH agonist | Active comparator | Not described Receives: Drug: Decapeptyl |
| hCG | Active comparator | Not described Receives: Drug: Ovitrel |
| dual triggering: GnRH agonist and hCG | Active comparator | Not described Receives: Drug: Ovitrel; Drug: Decapeptyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome is the number of mature oocytes
Measured: up to 12 months
number of embryos appropriate for transfer
Measured: up to 12 month
Secondary outcomes (1)
pregnancy rate
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Poor Ovarian ResponseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Jigal Haas MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144818
- Sponsor's protocol ID
- SHEBA-13-0438-JH-CTIL
- Status last verified
- Apr 2014
- First submitted
- 28 Apr 2014
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian
- ClinicalTrials.gov ID
- NCT02144818
- Acronym / sponsor ID
- SHEBA-13-0438-JH-CTIL
- Conditions
- Women With Poor Ovarian Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 22 May 2014 (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.
During the last decades, owing to the growing tendency of women to delay childbearing plans because of career and personal priorities, fertility specialists today are seeing more and more women with poor ovarian reserve and with poor ovarian response Controlled ovarian hyperstimulation (COH) is considered a important factor in the success of in vitro fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and, thereby, resulting in more than one embryo. However, owing to the extreme variability in ovarian response to COH, in a subgroup of patients with poor ovarian response, this method may yield a very small number of follicles After succeeding in maximal recruitment of the follicles, the triggering of ovulation is extremely important in order to achieve, as many as, mature oocytes.
Several studies have reported retrieval of more mature oocytes after GnRH agonist triggering compared to the number of oocytes retrieved after hCG. Among the possible advantages of GnRH agonist for final oocyte maturation is the simultaneous induction of an FSH surge. The role of the natural mid-cycle FSH surge is not fully clear. FSH was reported to induce LH receptor formation in luteinizing granulosa cells, and to promote oocyte nuclear maturation and cumulus expansion .
Another method described to trigger ovulation is the "Dual triggering"- GnRH agonist 40 h prior to ovum pickup and hCG added 6 h after the first trigger. The dual triggering was described as the treatment in cases with recurrent empty follicles.
The aim of the present study is to evaluate three different methods of ovulation triggering in women with poor ovarian response
Detailed description
Inclusion criteria:
- Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.
Exclusion criteria:
- Women with good ovarian response.
- Women with low ovarian response who are carriers of fragile X
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GnRH agonist | Active comparator | Drug: Decapeptyl |
| hCG | Active comparator | Drug: Ovitrel |
| dual triggering: GnRH agonist and hCG | Active comparator | Drug: Ovitrel, Drug: Decapeptyl |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.
Key exclusion criteria (2 listed)
- Women with good ovarian response.
- Women with low ovarian response who are carriers of fragile X
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 |
|---|---|---|
| OvitrelTriggering of ovulation with Ovitrel | Drug | dual triggering: GnRH agonist and hCG, hCG |
| DecapeptylTriggering with GnRH agonist | Drug | GnRH agonist, dual triggering: GnRH agonist and hCG |
Primary outcome
The main outcome is the number of mature oocytes
Time frame: up to 12 months
number of embryos appropriate for transfer
Time frame: up to 12 month
1 secondary outcome
pregnancy rate
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovitrel and Decapeptyl in people with Women With Poor Ovarian Response, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 May 2014. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main outcome is the number of mature oocytes (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 22 May 2014.