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

NCT02144818 | Unknown

• 1 other identifier: SHEBA-13-0438-JH-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Women With Poor Ovarian Response

Outcome Measures

Primary Outcomes (2)

• The main outcome is the number of mature oocytes

  up to 12 months

• number of embryos appropriate for transfer

  up to 12 month

Secondary Outcomes (1)

• pregnancy rate

  up to 12 months

Study Arms (3)

GnRH agonist

ACTIVE COMPARATOR

Drug: Decapeptyl

hCG

ACTIVE COMPARATOR

Drug: Ovitrel

dual triggering: GnRH agonist and hCG

ACTIVE COMPARATOR

Drug: Ovitrel; Drug: Decapeptyl

Interventions

Ovitrel DRUG

Triggering of ovulation with Ovitrel

dual triggering: GnRH agonist and hCG; hCG

Decapeptyl DRUG

Triggering with GnRH agonist

GnRH agonist; dual triggering: GnRH agonist and hCG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Interventions

Triptorelin Pamoate

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Gynecologist and Obstetrician

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 22, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 22, 2014

Record last verified: 2014-04

Locations

IL (1)