Clomiphene Citrate in Combination With Gonadotropins for Ovarian Stimulation in Women With Poor Ovarian Response.

NCT ID: NCT02237755

Last Updated: 2014-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

Brief 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 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.

Conditions

Female Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clomiphene citrate

Administration of Clomiphene citrate in combination with gonadotropins according to a short stimulation GnRH antagonists protocol.

Group Type: ACTIVE_COMPARATOR

Clomiphene citrate

Intervention Type: DRUG

clomiphene citrate 100mg/day will be added to the standard gonadotropin regiment

Gonadotropins

Intervention Type: DRUG

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.

Gonadotropins

Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists.

Group Type: ACTIVE_COMPARATOR

Clomiphene citrate

Intervention Type: DRUG

clomiphene citrate 100mg/day will be added to the standard gonadotropin regiment

Gonadotropins

Intervention Type: DRUG

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.

Interventions

Clomiphene citrate

clomiphene citrate 100mg/day will be added to the standard gonadotropin regiment

Intervention Type: DRUG

Gonadotropins

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.

Intervention Type: DRUG

Other Intervention Names

Clomiphene citrate 50 mg/tab; Cerpafar 50 mg/tab; Menopur 75IU , Gonal

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lito Maternity Hospital

OTHER

Sponsor Role: collaborator

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Nikos Vlahos

Associate Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikos Vlahos, Assoc. Prof.

Role: STUDY_CHAIR

University of Athens, 2nd Department of Obstetrics and Gynecology

Olga Triantafyllidou, MD

Role: PRINCIPAL_INVESTIGATOR

University of Athens School of Medicine

Central Contacts

Nikos Vlahos, MD

Role: CONTACT

nikosvlahos@med.uoa.gr

30 210 7286000

Olga Triantafyllidou, MD

Role: CONTACT

triantafyllidouolga@yahoo.com

30 2107485591

Other Identifiers

NV25042014

Identifier Type: -

Identifier Source: org_study_id