Female InfertilityPhase 2/3NCT02237755
Clomiphene Citrate in Combination With Gonadotropins for Ovarian Stimulation in Women With Poor Ovarian Response.
A Phase 2/3 study testing Clomiphene citrate and Gonadotropins in people with Female Infertility, run by University of Athens.
Trial summary
Coadministration of various drugs used for ovarian stimulation can increase the efficiency of IVF especially in poor responders. The investigators hypothesize that ovarian response of those patients could improve by using combination of clomiphene citrate with gonadotropins in infertile women with poor response to… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility
- What is being tested?
- Clomiphene citrate and Gonadotropins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 2/3
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with poor response to ovarian stimulation. The definition of poor response was based on the presence of at least one of the following criteria: Age > 40 years old, day 2 FSH >9.5 mIU/ml, AMH < 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG.
Who cannot join
- All other women that do not fulfill the above mentioned criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Randomized Trial on the Effect of Clomiphene Citrate Administration in Women With Poor Ovarian Reserve Undergoing Controlled Ovarian Stimulation for IVF. Impact on Stimulation Characteristics and Pregnancy Outcome.
Coadministration of various drugs used for ovarian stimulation can increase the efficiency of IVF especially in poor responders. The investigators hypothesize that ovarian response of those patients could improve by using combination of clomiphene citrate with gonadotropins in infertile women with poor response to gonadotrophin administration only.
Read the detailed description
Patients diagnosed with poor ovarian response will be included in the study. The definition of poor response was based on the presence of at least one of the following criteria: Age > 40 years old, day 2 FSH >9.5 mIU/ml, AMH < 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG. All patients will be counseled regarding their prognosis and other treatment options including oocyte donation as well as adoption were also presented and discussed in detail. Early follicular phase FSH, estradiol (E2) and Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment. Women in the Clomiphene group will receive 100-150 mg of Clomiphene citrate once per day for 5 days in combination with gonadotropins according to short GnRH-antagonist protocol: all women will have measurements of serum FSH and estradiol and a pelvic sonogram on the second day of their cycle. Providing that serum FSH is < 17 mIU/ml and estradiol is < 70 pg/ml on day 2 , ovarian stimulation will be initiated with 100-150 mg of Clomiphene citrate in combination with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH. All patients will be re-evaluated on day 5 of the stimulation, and dosage adjustments will be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated. When at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl, Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. All patients will undergo ICSI. Patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval. Women in the Gonadotropin group will receive only gonadotropins according to short GnRH-antagonist protocol as it was mentioned above.
- Conditions
- Female Infertility
- Being tested
- Clomiphene citrate, Gonadotropins
- Keywords
- Clomiphene citrate, IVF, Pregnancy Rates, Ovarian Reserve
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene citrateDrug
Also called Clomiphene citrate 50 mg/tab, Cerpafar 50 mg/tab
clomiphene citrate 100mg/day will be added to the standard gonadotropin regiment
GonadotropinsDrug
Also called Menopur 75IU , Gonal
All patients will be stimulated with a fixed GnRH-antagonist protocol. Ovarian stimulation will be initiated with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH.
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate | Active comparator | Administration of Clomiphene citrate in combination with gonadotropins according to a short stimulation GnRH antagonists protocol. Receives: Drug: Clomiphene citrate; Drug: Gonadotropins |
| Gonadotropins | Active comparator | Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists. Receives: Drug: Clomiphene citrate; Drug: Gonadotropins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
At the completion of the ovarian stimulation patients that will proceed to transfer and have a positive pregnancy test will have sonographic evaluation for confirmation of clinical pregnancy.
Measured: 14 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Lito Maternity Hospital
- Responsible party
- Principal investigator, Nikos Vlahos, University of Athens
- Investigators
- Nikos Vlahos, Assoc. Prof., Study chair, University of Athens, 2nd Department of Obstetrics and GynecologyOlga Triantafyllidou, MD, Principal investigator, University of Athens School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237755
- Sponsor's protocol ID
- NV25042014
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial on the Effect of Clomiphene Citrate Administration in Women With Poor Ovarian Reserve Undergoing Controlled Ovarian Stimulation for IVF. Impact on Stimulation Characteristics and Pregnancy Outcome.
- ClinicalTrials.gov ID
- NCT02237755
- Acronym / sponsor ID
- NV25042014
- Conditions
- Female Infertility
- Keywords
- Clomiphene citrate, IVF, Pregnancy Rates, Ovarian Reserve
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Collaborators
- Lito Maternity Hospital
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Sep 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.
Coadministration of various drugs used for ovarian stimulation can increase the efficiency of IVF especially in poor responders. The investigators hypothesize that ovarian response of those patients could improve by using combination of clomiphene citrate with gonadotropins in infertile women with poor response to gonadotrophin administration only.
Detailed description
Patients diagnosed with poor ovarian response will be included in the study. The definition of poor response was based on the presence of at least one of the following criteria: Age > 40 years old, day 2 FSH >9.5 mIU/ml, AMH < 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG. All patients will be counseled regarding their prognosis and other treatment options including oocyte donation as well as adoption were also presented and discussed in detail. Early follicular phase FSH, estradiol (E2) and Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment. Women in the Clomiphene group will receive 100-150 mg of Clomiphene citrate once per day for 5 days in combination with gonadotropins according to short GnRH-antagonist protocol: all women will have measurements of serum FSH and estradiol and a pelvic sonogram on the second day of their cycle. Providing that serum FSH is < 17 mIU/ml and estradiol is < 70 pg/ml on day 2 , ovarian stimulation will be initiated with 100-150 mg of Clomiphene citrate in combination with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH. All patients will be re-evaluated on day 5 of the stimulation, and dosage adjustments will be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated. When at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl, Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. All patients will undergo ICSI. Patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval. Women in the Gonadotropin group will receive only gonadotropins according to short GnRH-antagonist protocol as it was mentioned above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate | Active comparator | Drug: Clomiphene citrate, Drug: GonadotropinsAdministration of Clomiphene citrate in combination with gonadotropins according to a short stimulation GnRH antagonists protocol. |
| Gonadotropins | Active comparator | Drug: Clomiphene citrate, Drug: GonadotropinsPatients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with poor response to ovarian stimulation. The definition of poor response was based on the presence of at least one of the following criteria: Age > 40 years old, day 2 FSH >9.5 mIU/ml, AMH < 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG.
Key exclusion criteria (1 listed)
- All other women that do not fulfill the above mentioned criteria
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 |
|---|---|---|
| Clomiphene citrateAlso: Clomiphene citrate 50 mg/tab, Cerpafar 50 mg/tabclomiphene citrate 100mg/day will be added to the standard gonadotropin regiment | Drug | Clomiphene citrate, Gonadotropins |
| GonadotropinsAlso: Menopur 75IU , GonalAll patients will be stimulated with a fixed GnRH-antagonist protocol. Ovarian stimulation will be initiated with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH. | Drug | Clomiphene citrate, Gonadotropins |
Primary outcome
Clinical pregnancy
Time frame: 14 days after embryo transfer
At the completion of the ovarian stimulation patients that will proceed to transfer and have a positive pregnancy test will have sonographic evaluation for confirmation of clinical pregnancy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 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.
Nikos Vlahos, Assoc. Prof. study chair
University of Athens, 2nd Department of Obstetrics and Gynecology
Olga Triantafyllidou, MD principal investigator
University of Athens School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clomiphene citrate and Gonadotropins in people with Female Infertility, run by University of Athens.
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 1 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 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Nikos Vlahos, MD (30 210 7286000, nikosvlahos@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy (time frame: 14 days after embryo transfer). 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 11 Sep 2014.