Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity

NCT01507376 | Completed Phase 3 DMC

• 1 other identifier: Royan-Emb-012
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective randomized clinical trial to compare the efficacy of the urinary and recombinant hCG on oocyte quality for ovulation induction in women undergoing IVF/ICSI.

Conditions

In Vitro Fertilization

Keywords

Ovulation induction; urinary; hCG; recombinant hCG

Outcome Measures

Primary Outcomes (1)

• Number of mature oocytes

  evaluation the effect of recombinant hcg on number of oocytes up to 1 hour after oocytes retrieval

  Up to1 hour after oocyte retrieval

Secondary Outcomes (6)

• number of retrieved oocytes per number of aspirated follicles proportion

  up to 1 hour after oocyte retrieval

• fertilization rate

  in 1 day after oocyte retrieval

• implantation rate

  4 weeks after embryo transfer

• OHSS occurrence rate will be compared between three groups

  from embryo transfer day up to pregnancy test

• chemical pregnancy rates

  2 weeks after embryo transfer

Study Arms (3)

A: recombinant hCG(250 µg Ovitrell)

EXPERIMENTAL

1- Group A consisted of 60 infertile women who received recombinant hCG(250 µg Ovitrelle)

Drug: recombinant hCG

B: recombinant hCG(500 µg Ovitrell)

EXPERIMENTAL

2- Group B consisted of 60 infertile women who received recombinant hCG(500 µg Ovitrelle)

Drug: recombinant hCG

C: urinary hCG

EXPERIMENTAL

3- Group C consisted of 60 infertile patients received 10,000 IU urinary hCG

Drug: urinary hCG

Interventions

recombinant hCG DRUG

recombinant hCG(250 µg Ovitrell)

A: recombinant hCG(250 µg Ovitrell)

urinary hCG DRUG

10,000 IU urinary hCG

C: urinary hCG

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Indication for IVF/ICSI and Long Protocol ovarian stimulation
• Age 20-37
• Body mass index (BMI) ≤ 30 kg/m2
• Regular menstrual cycles of 25-35 days
• Tubal or male factor
• Existence of both ovary and normal uterine cavity
• Basal FSH≥10
• Physical health

You may not qualify if:

• Poly Cystic Ovarian Syndrome patients
• Contraindications of gonadotropins administration
• Poor response to ovulation induction in recent cycle

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

• Madani T, Mohammadi Yeganeh L, Ezabadi Z, Hasani F, Chehrazi M. Comparing the efficacy of urinary and recombinant hCG on oocyte/follicle ratio to trigger ovulation in women undergoing intracytoplasmic sperm injection cycles: a randomized controlled trial. J Assist Reprod Genet. 2013 Feb;30(2):239-45. doi: 10.1007/s10815-012-9919-3. Epub 2012 Dec 29.

  PMID: 23274511 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Taraneh Madani, MD

  gynecology scientist

  STUDY DIRECTOR

• Ladan Mohmmadi yeganeh, MSc

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: January 10, 2012
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: June 1, 2013
• Last Updated: April 25, 2014

Record last verified: 2010-10

Locations

IR (1)