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

GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian

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

Study Overview

• Status: Unknown
• Conditions: Women With Poor Ovarian Response
• Intervention / Treatment: Drug: Decapeptyl; Drug: Ovitrel

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Jigal Haas, M.D; Phone Number: 0972524651054; Email: jigalh@hotmail.com
    • Principal Investigator: Jigal Haas, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
pregnancy rate	up to 12 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: SHEBA-13-0438-JH-CTIL