InfertilityPhase 4NCT01419353
Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol
A Phase 4 study testing estradiol valerate in people with Infertility, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments. Read more about this study
- Who is it for?
- Ages Up to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- estradiol valerate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Jun 2013
- 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 Up to 38 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- IVF treatment in the following indications: Male, Mechanical, Unexplained
- Age<38 years
- Treatment Cycle number 1-4
Who cannot join
- Ovulatory disorder as an indication for IVF
- Repeated failure in previous IVF treatments (> than 4 cycles)
- Sperm used for treatment was retrieved by surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments.
Read the detailed description
A randomised controlled trial in which study group will be given estrogen derivative before ovarian stimulation in GnRH antagonist protocol and compared to the classical GnRH agonist protocol.Estrogen will be given P.O , "PROGYNOVA' , in a dose of 2 mg /d, starting day 2 of menses and until first Monday to follow. Main outcome measure will be ability to control the ovum pickup day, calculated as a rate of ideal pickups divided by the entire pickup number. All women enrolled will be under 38 years of age, with a clear indication for IVF other than ovulatory dysfunction. women with past 4 treatment failures will be excluded as well as cases in which sperm achieved in surgical methods.
- Conditions
- Infertility
- Being tested
- estradiol valerate
- Keywords
- Infertility, IVF, Estrogen
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol valerateDrug
2 mg P.O / day for 1-6 days.
| Study group | Role | What they receive |
|---|---|---|
| Follicular Estrogen, Antagonist, IVF | Experimental | Follicular Estrogen in Antagonist IVF protocol Receives: Drug: estradiol valerate |
| long IVF protocol | Active comparator | long IVF protocol Receives: Drug: estradiol valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovum pickup rate that took place between Sunday to Thursday without a compromise
number of Pickups that took place between Sunday to Thursday (without a compromise in treatment) \ by the entire pickup number
Measured: a year
Secondary outcomes (1)
pregnancy rate
comparison of pregnancy rate between the 2 groups. calculated per cycle
Measured: a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Shulman, MD, Study chair, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419353
- Sponsor's protocol ID
- Antagonist_prog
- Status last verified
- Aug 2011
- First submitted
- 1 Aug 2011
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hershko Klement A, Berkovitz A, Wiser A, Gonen O, Amichay K, Cohen I, Ghetler Y, Shulman A. GnRH-antagonist programming versus GnRH agonist protocol: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Feb;185:170-3. doi: 10.1016/j.ejogrb.2014.12.021. Epub 2014 Dec 29.
PubMed 25594526
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol
- ClinicalTrials.gov ID
- NCT01419353
- Acronym / sponsor ID
- Antagonist_prog
- Conditions
- Infertility
- Keywords
- Infertility, IVF, Estrogen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Aug 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.
The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments.
Detailed description
A randomised controlled trial in which study group will be given estrogen derivative before ovarian stimulation in GnRH antagonist protocol and compared to the classical GnRH agonist protocol.Estrogen will be given P.O , "PROGYNOVA' , in a dose of 2 mg /d, starting day 2 of menses and until first Monday to follow. Main outcome measure will be ability to control the ovum pickup day, calculated as a rate of ideal pickups divided by the entire pickup number. All women enrolled will be under 38 years of age, with a clear indication for IVF other than ovulatory dysfunction. women with past 4 treatment failures will be excluded as well as cases in which sperm achieved in surgical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follicular Estrogen, Antagonist, IVF | Experimental | Drug: estradiol valerateFollicular Estrogen in Antagonist IVF protocol |
| long IVF protocol | Active comparator | Drug: estradiol valeratelong IVF protocol |
Who may qualify
- Ages
- Up to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- IVF treatment in the following indications: Male, Mechanical, Unexplained
- Age<38 years
- Treatment Cycle number 1-4
Key exclusion criteria (3 listed)
- Ovulatory disorder as an indication for IVF
- Repeated failure in previous IVF treatments (> than 4 cycles)
- Sperm used for treatment was retrieved by surgical procedure
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 |
|---|---|---|
| estradiol valerate2 mg P.O / day for 1-6 days. | Drug | Follicular Estrogen, Antagonist, IVF, long IVF protocol |
Primary outcome
ovum pickup rate that took place between Sunday to Thursday without a compromise
Time frame: a year
number of Pickups that took place between Sunday to Thursday (without a compromise in treatment) \ by the entire pickup number
1 secondary outcome
pregnancy rate
Time frame: a year
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 24 Dec 2013.
- Derived from this study: PubMed 25594526Hershko Klement A, Berkovitz A, Wiser A, Gonen O, Amichay K, Cohen I, Ghetler Y, Shulman A. GnRH-antagonist programming versus GnRH agonist protocol: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Feb;185:170-3. doi: 10.1016/j.ejogrb.2014.12.021. Epub 2014 Dec 29.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Adrian Shulman, MD study chair
Meir Medical Center
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 estradiol valerate in people with Infertility, run by Meir 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 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: finished, as of the sponsor's last update on 24 Dec 2013. 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.
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?
ovum pickup rate that took place between Sunday to Thursday without a compromise (time frame: a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01419353, which also lists 1 linked publication.
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 24 Dec 2013.