Final Oocyte Maturation Via Administration of GnRH Agonists Followed By Luteal Support With hCG

NCT01638026 | Completed Phase 4 DMC

• 1 other identifier: emc-0060-12-CTIL
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objectives:

1. 1.To prove that the use of GnHR agonist for final oocyte maturation results in a higher percentage of mature oocytes than the use of hCG.
2. 2.To show an advantage in women's satisfaction in the proposed protocol versus the standard antagonist protocol In the study group women will receive GnRH agonist for oocyte maturation, followed by ovum pick-up which will be performed 35 hours later. Embryo transfer will be performed 48-72 hours after ovum pick-up. Luteal support will include HCG 1500 IU. Blood samples for BHCG, progesterone and estradiol will be obtained 14 days after embryo transfer.

Conditions

Infertility

Keywords

Gnrh agonist

Outcome Measures

Primary Outcomes (1)

• fertilization rate

  4 weeks

Secondary Outcomes (1)

• satisfaction, no. of oocyte, pregnancy rate, no. of embryos, quality of embryos

  4 weeks

Study Arms (1)

Gnrh agonist , hcg

EXPERIMENTAL

Gnrh agonist for final oocyte maturation, hcg for luteal support

Drug: TRIPTORELIN ACETATE, hCG

Interventions

TRIPTORELIN ACETATE, hCG DRUG

In the study group women will receive GnRH agonist (decapeptyl 0.2 mg) for oocyte maturation, followed by ovum pick-up which will be performed 35 hours later. Embryo transfer will be performed 48-72 hours after ovum pick-up. Luteal support will include HCG 1500 IU.

Gnrh agonist , hcg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients who are eligible for in vitro fertilization using an antagonist protocol

You may not qualify if:

• patients diagnosed with hypogonadotrophic hypogonadism, sensitivity to any of the drugs used in the study A patient enrolled in the study who, as a result of ovarian stimulation, responds in a way that puts her in risk of developing ovarian hyperstimulation, will be ultimately excluded from the study.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Hemek medical centre

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

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: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: July 8, 2012
• First Posted: July 11, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

IL (1)