- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02237755
Clomiphene Citrate in Combination With Gonadotropins for Ovarian Stimulation in Women With Poor Ovarian Response.
September 9, 2014 updated by: Nikos Vlahos, University of Athens
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nikos Vlahos, MD
- Phone Number: 30 210 7286000
- Email: nikosvlahos@med.uoa.gr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- All other women that do not fulfill the above mentioned criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Clomiphene citrate
Administration of Clomiphene citrate in combination with gonadotropins according to a short stimulation GnRH antagonists protocol.
|
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.
Other Names:
clomiphene citrate 100mg/day will be added to the standard gonadotropin regiment
Other Names:
|
Active Comparator: Gonadotropins
Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists.
|
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.
Other Names:
clomiphene citrate 100mg/day will be added to the standard gonadotropin regiment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14 days after embryo transfer
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Nikos Vlahos, Assoc. Prof., University of Athens, 2nd Department of Obstetrics and Gynecology
- Principal Investigator: Olga Triantafyllidou, MD, University of Athens School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
November 1, 2014
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
September 9, 2014
First Submitted That Met QC Criteria
September 9, 2014
First Posted (Estimate)
September 11, 2014
Study Record Updates
Last Update Posted (Estimate)
September 11, 2014
Last Update Submitted That Met QC Criteria
September 9, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infertility
- Infertility, Female
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Anticoagulants
- Estrogen Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Chelating Agents
- Sequestering Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Calcium Chelating Agents
- Citric Acid
- Sodium Citrate
- Clomiphene
- Enclomiphene
- Zuclomiphene
Other Study ID Numbers
- NV25042014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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