Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF

NCT ID: NCT02099916

Last Updated: 2014-09-10

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

Poor responders to ovarian stimulation represents one of the most frustrating problems in reproductive medicine. The investigators hypothesize that ovarian response of those patients could improve by treating these patients with 25 mg DHEA tid for 12 weeks prior to stimulation.

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. All patients will be aware that the use of DHEA is experimental and informed consent was obtained for those agreeing to use the medication. Women in the DHEA group will receive 25 mg of DHEA three times a day for at least 12 weeks. During this period, women will be subjected to monthly measurements of early follicular phase FSH and estradiol. Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment and at the end of the observation period. Patients will be stimulated with a short GnRH-antagonist protocol. Briefly, 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 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.

Conditions

Efficacy of DHEA; Pregnancy Rate; Diminished Ovarian Reserve; Changes in AMH

Study Design

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

Study Groups

gonadotropins plus DHEA

Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists. Prior to the stimulation will be treated with DHEA 25 mg PO tid for 12 weeks.

Group Type: ACTIVE_COMPARATOR

gonadotropins plus DHEA

Intervention Type: DRUG

Women in the DHEA group will received 25 mg of DHEA three times a day for at least 12 weeks.

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

gonadotropins plus DHEA

Intervention Type: DRUG

Women in the DHEA group will received 25 mg of DHEA three times a day for at least 12 weeks.

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

gonadotropins plus DHEA

Women in the DHEA group will received 25 mg of DHEA three times a day for at least 12 weeks.

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

DHEA; 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, AssProfessor

Role: STUDY_CHAIR

University of Athens, 2nd Department of Obstetrics and Gynecology

Central Contacts

Nikos vlahos, MD

Role: CONTACT

nikosvlahos@med.uoa.gr

30 210 7286000 ext. 256

Olga Triantafillidou, MD

Role: CONTACT

triantafyllidouolga@yahoo.com

30 2107485591

Other Identifiers

NV04222014

Identifier Type: -

Identifier Source: org_study_id