Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection

NCT01509833 | Completed Phase 3 DMC

• 1 other identifier: Royan-Emb-013
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment.

Conditions

Infertility

Keywords

ICSI Ovarian stimulation; hCG low dose; Oocyte maturity; poor respond

Outcome Measures

Primary Outcomes (1)

• Number of mature oocytes

  Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval

  Up to 2 hours after oocyte retrieval

Secondary Outcomes (8)

• Number of retrieved oocytes

  Up to 1 hour after oocyte retrieval

• Number of generated embryos

  Up to 48-72 hours after oocyte retrieval

• Quality of generated embryos

  Up to 48-72 hours after oocyte retrieval

• Number of transferred embryos

  on the time of embryo transfer

• Quality of transferred embryos

  on the time of embryo transfer

Study Arms (3)

rFSH

EXPERIMENTAL

Administration of recombinant FSH for ovarian stimulation.

Drug: rFSH

hCG(100IU)

EXPERIMENTAL

Administration of late follicular low dose hCG(100U) for ovarian stimulation.

Drug: hCG

hCG(200IU)

EXPERIMENTAL

Administration of late follicular low dose hCG(200IU) for ovarian stimulation.

Drug: hCG

Interventions

rFSH DRUG

Administration of rFSH for ovarian stimulation.

rFSH

hCG DRUG

Administration of late follicular low dose hCG(100IU) for ovarian stimulation.

hCG(100IU)

Eligibility Criteria

• Age: 37 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Poor ovarian response to ovulation induction according to the ESHRE definition\[20\] and presence of at least 2 of the criteria needed to define poor responders including advanced maternal age, history of low ovarian response in previous IVF/ICSI treatments and abnormal ovarian reserve test(Antral Follicle number \< 5)
• indication for ICSI treatment, second or third cycle
• Age 37 to 43 years
• Body mass index (BMI) ≤ 30 kg/m2
• The presence of two functional ovaries and no previous ovarian surgery
• The presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation
• Basal (day 2 or 3) serum FSH levels ≤13 IU/L
• Normal semen analysis
• No history or signs of endometriosis
• No untreated endocrinologic disease

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

• Madani T, Mohammadi Yeganeh L, Khodabakhshi S, Akhoond MR, Hasani F. Efficacy of low dose hCG on oocyte maturity for ovarian stimulation in poor responder women undergoing intracytoplasmic sperm injection cycle: a randomized controlled trial. J Assist Reprod Genet. 2012 Nov;29(11):1213-20. doi: 10.1007/s10815-012-9854-3. Epub 2012 Sep 7.

  PMID: 22956348 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Tahereh Madani, MD

  scientist

  STUDY DIRECTOR

• Ladan Mohmmadi yeganeh, MSc

  scientist

  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: January 5, 2012
• First Posted: January 13, 2012
• Study Start: October 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 13, 2012

Record last verified: 2009-08

Locations

IR (1)