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

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02144818

Collaborator

(none)

Enrollment

Location

Arms

17.9

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Women With Poor Ovarian Response	Drug: Ovitrel Drug: Decapeptyl	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: GnRH agonist	Drug: Decapeptyl Triggering with GnRH agonist
Active Comparator: hCG	Drug: Ovitrel Triggering of ovulation with Ovitrel
Active Comparator: dual triggering: GnRH agonist and hCG	Drug: Ovitrel Triggering of ovulation with Ovitrel Drug: Decapeptyl Triggering with GnRH agonist

Arm

Intervention/Treatment

Active Comparator: GnRH agonist

Drug: Decapeptyl

Triggering with GnRH agonist

Active Comparator: hCG

Drug: Ovitrel

Triggering of ovulation with Ovitrel

Active Comparator: dual triggering: GnRH agonist and hCG

Drug: Ovitrel

Triggering of ovulation with Ovitrel

Drug: Decapeptyl

Triggering with GnRH agonist

Outcome Measures

Primary Outcome Measures

The main outcome is the number of mature oocytes [up to 12 months]
number of embryos appropriate for transfer [up to 12 month]

Secondary Outcome Measures

pregnancy rate [up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba medical center	Ramat Gan		Israel

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Jigal Haas MD, Senior Gynecologist and Obstetrician, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT02144818

Other Study ID Numbers:

SHEBA-13-0438-JH-CTIL

First Posted:

May 22, 2014

Last Update Posted:

May 22, 2014

Last Verified:

Apr 1, 2014

Additional relevant MeSH terms:

Triptorelin Pamoate

Study Results

No Results Posted as of May 22, 2014