InfertilityPhase 4NCT01489852
Estrogen Pretreatment Prior to GnRH Antagonist Protocol
A Phase 4 study testing 17beta-estradiol in people with Infertility, run by Gemer at 1 site in France.
Trial summary
The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- 17beta-estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2006to May 2011
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- regular normo-ovulatory cycles (28 to 35 days)
- age < 38 years,
- body mass index (BMI) between 18 and 30
- first or second IVF/ICSI attempt
Who cannot join
- high basal levels of serum FSH or E2,
- less than 5 follicles at the antral follicular count performed on day 3 of a spontaneous cycle,
- history of high (>20 oocytes) or low (< 5 oocytes) ovarian response in a previous IVF attempt
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Medecine de la Reproduction, Hôpital Jean Verdier
Bondy, Île-de-France Region, 93140
About this study
Official title: Interest of a Steroid Pre-treatment Prior to IVF Protocol With Ovarian Stimulation by Recombinant FSH and With LH Surge Blockage by Daily GnRH Antagonist
The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.
- Conditions
- Infertility
- Being tested
- 17beta-estradiol
- Keywords
- Assisted reproductive treatment, GnRH antagonist, Estrogen pre-treatment, Ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17beta-estradiolDrug
Pretreatment with 17beta-estradiol (Provames®, Aventis, Paris, France) was administered daily (2 mg twice a day) during the cycle preceding the IVF/ICSI cycle, starting 7 days before the predicted onset of menses and administered up until to the following Thursday after the occurrence of menses.
| Study group | Role | What they receive |
|---|---|---|
| Estrogen pre-treatment | Active comparator | Not described Receives: Drug: 17beta-estradiol |
| Control | No intervention | The control group did not receive any pre-treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of retrieved oocytes
Measured: at the ovarian puncture, 36 hours post HCG administration
Secondary outcomes (5)
pregnancy rate
Measured: at pregnancy test and at 6 Week US examination
delivery rate
Measured: 9 months later
number of obtained embryos
Measured: 2 days after in vitro fertilization
duration of FSH administration
number of days of administration
Measured: at the end of ovarian stimulation usually after a mean of 12 days of administration
Total FSH dose
daily dose x number of days of administration
Measured: at the end of ovarian stimulation usually after a mean of 12 days of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startDec 2006
- Primary completionJul 2010
- Study completionMay 2011
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
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gemer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr CEDRIN-DURNERIN Isabelle, Gemer
- Investigators
- Jean Noel Hugues, MD, PhD, Study director, Hôpital Jean VerdierIsabelle cedrin-durnerin, MD, Principal investigator, Hôpital Jean Verdier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489852
- Sponsor's protocol ID
- E2PRETREATMENT
- Status last verified
- Dec 2011
- First submitted
- 28 Nov 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.
PubMed 22464760
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Steroid Pre-treatment Prior to IVF Protocol With Ovarian Stimulation by Recombinant FSH and With LH Surge Blockage by Daily GnRH Antagonist
- ClinicalTrials.gov ID
- NCT01489852
- Acronym / sponsor ID
- E2PRETREATMENT
- Conditions
- Infertility
- Keywords
- Assisted reproductive treatment, GnRH antagonist, Estrogen pre-treatment, Ovarian stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- GemerUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 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.
The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estrogen pre-treatment | Active comparator | Drug: 17beta-estradiol |
| Control | No intervention | –The control group did not receive any pre-treatment. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- regular normo-ovulatory cycles (28 to 35 days)
- age < 38 years,
- body mass index (BMI) between 18 and 30
- first or second IVF/ICSI attempt
Key exclusion criteria (3 listed)
- high basal levels of serum FSH or E2,
- less than 5 follicles at the antral follicular count performed on day 3 of a spontaneous cycle,
- history of high (>20 oocytes) or low (< 5 oocytes) ovarian response in a previous IVF attempt
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 |
|---|---|---|
| 17beta-estradiolPretreatment with 17beta-estradiol (Provames®, Aventis, Paris, France) was administered daily (2 mg twice a day) during the cycle preceding the IVF/ICSI cycle, starting 7 days before the predicted onset of menses and administered up until to the following Thursday after the occurrence of menses. | Drug | Estrogen pre-treatment |
Primary outcome
number of retrieved oocytes
Time frame: at the ovarian puncture, 36 hours post HCG administration
5 secondary outcomes
pregnancy rate
Time frame: at pregnancy test and at 6 Week US examination
delivery rate
Time frame: 9 months later
number of obtained embryos
Time frame: 2 days after in vitro fertilization
duration of FSH administration
Time frame: at the end of ovarian stimulation usually after a mean of 12 days of administration
Total FSH dose
Time frame: at the end of ovarian stimulation usually after a mean of 12 days of administration
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 12 Dec 2011.
- Derived from this study: PubMed 22464760Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.
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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.
Jean Noel Hugues, MD, PhD study director
Hôpital Jean Verdier
Isabelle cedrin-durnerin, MD principal investigator
Hôpital Jean Verdier
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 17beta-estradiol in people with Infertility, run by Gemer at 1 site in France.
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 4 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 12 Dec 2011. 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 France. 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?
number of retrieved oocytes (time frame: at the ovarian puncture, 36 hours post HCG administration). 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 NCT01489852, 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 12 Dec 2011.