GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian Response

NCT ID: NCT02144818

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-07-31

Brief Summary

During the last decades, owing to the growing tendency of women to delay childbearing plans because of career and personal priorities, fertility specialists today are seeing more and more women with poor ovarian reserve and with poor ovarian response Controlled ovarian hyperstimulation (COH) is considered a important factor in the success of in vitro fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and, thereby, resulting in more than one embryo. However, owing to the extreme variability in ovarian response to COH, in a subgroup of patients with poor ovarian response, this method may yield a very small number of follicles After succeeding in maximal recruitment of the follicles, the triggering of ovulation is extremely important in order to achieve, as many as, mature oocytes.

Several studies have reported retrieval of more mature oocytes after GnRH agonist triggering compared to the number of oocytes retrieved after hCG. Among the possible advantages of GnRH agonist for final oocyte maturation is the simultaneous induction of an FSH surge. The role of the natural mid-cycle FSH surge is not fully clear. FSH was reported to induce LH receptor formation in luteinizing granulosa cells, and to promote oocyte nuclear maturation and cumulus expansion .

Another method described to trigger ovulation is the "Dual triggering"- GnRH agonist 40 h prior to ovum pickup and hCG added 6 h after the first trigger. The dual triggering was described as the treatment in cases with recurrent empty follicles.

The aim of the present study is to evaluate three different methods of ovulation triggering in women with poor ovarian response

Detailed Description

Inclusion criteria:

• Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.

Exclusion criteria:

• Women with good ovarian response.
• Women with low ovarian response who are carriers of fragile X

Conditions

Women With Poor Ovarian Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GnRH agonist

Group Type: ACTIVE_COMPARATOR

Decapeptyl

Intervention Type: DRUG

Triggering with GnRH agonist

hCG

Group Type: ACTIVE_COMPARATOR

Ovitrel

Intervention Type: DRUG

Triggering of ovulation with Ovitrel

dual triggering: GnRH agonist and hCG

Group Type: ACTIVE_COMPARATOR

Ovitrel

Intervention Type: DRUG

Triggering of ovulation with Ovitrel

Decapeptyl

Intervention Type: DRUG

Triggering with GnRH agonist

Interventions

Ovitrel

Triggering of ovulation with Ovitrel

Intervention Type: DRUG

Decapeptyl

Triggering with GnRH agonist

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women with low ovarian response according to the Bologna criteria, undergoing IVF treatments for this cause.

Exclusion Criteria

• Women with good ovarian response.
• Women with low ovarian response who are carriers of fragile X

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Jigal Haas MD

Senior Gynecologist and Obstetrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheba medical center

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Jigal Haas, M.D

Role: primary

jigalh@hotmail.com

0972524651054

Other Identifiers

SHEBA-13-0438-JH-CTIL

Identifier Type: -

Identifier Source: org_study_id