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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01509833
First received: January 5, 2012
Last updated: January 10, 2012
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
 Drug: rFSH
Drug: hCG
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Low Dose hCG on Oocyte Maturity for Ovarian Stimulation in Poor Responder Women Undergoing ICSI: a Prospective Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Number of mature oocytes [ Time Frame: Up to 2 hours after oocyte retrieval ] [ Designated as safety issue: Yes ]
    Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval


Secondary Outcome Measures:
  • Number of retrieved oocytes [ Time Frame: Up to 1 hour after oocyte retrieval ] [ Designated as safety issue: Yes ]
    Evaluation the number of retrieved oocytes Up to 1 hour after oocyte retrieval

  • Number of generated embryos [ Time Frame: Up to 48-72 hours after oocyte retrieval ] [ Designated as safety issue: Yes ]
    Evaluation the number of generated embryos up to 48-72 hours after oocyte retrieval.

  • Quality of generated embryos [ Time Frame: Up to 48-72 hours after oocyte retrieval ] [ Designated as safety issue: Yes ]
    Evaluation the Quality of generated embryos up to 48-72 hours after oocyte retrieval.

  • Number of transferred embryos [ Time Frame: on the time of embryo transfer ] [ Designated as safety issue: Yes ]
    Evaluation the number of transferred embryos on the time of embryo transfer.

  • Quality of transferred embryos [ Time Frame: on the time of embryo transfer ] [ Designated as safety issue: Yes ]
    Evaluation the quality of transferred embryos on the time of embryo transfer.

  • implantation rate [ Time Frame: 4 weeks after embryo transfer ] [ Designated as safety issue: Yes ]
    Evaluation the implantation rate 4 weeks after embryo transfer.

  • chemical pregnancy rates [ Time Frame: 2 weeks after embryo transfer ] [ Designated as safety issue: Yes ]
    Evaluation the chemical pregnancy rates 2 weeks after embryo transfer.

  • clinical pregnancy rates [ Time Frame: 4 weeks after embryo transfer ] [ Designated as safety issue: Yes ]
    Evaluation the clinical pregnancy rates 4 weeks after embryo transfer.


Enrollment: 73
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFSH
Administration of recombinant FSH for ovarian stimulation.
 Drug: rFSH
Administration of rFSH for ovarian stimulation.
Experimental: hCG(100IU)
Administration of late follicular low dose hCG(100U) for ovarian stimulation.
 Drug: hCG
Administration of late follicular low dose hCG(100IU) for ovarian stimulation.
Experimental: hCG(200IU)
Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
 Drug: hCG
Administration of late follicular low dose hCG(200IU) for ovarian stimulation.

Detailed Description:

In this study all eligible patients were randomly allocated into three study groups by a permuted block randomization method: group A (control group) received only recombinant FSH, group B received rFSH supplemented by 100IU hCG in the late follicular phase. Group C received rFSH supplemented by 200IU hCG in the late follicular phase.

All of the patients underwent a standard long protocol and received GnRH-a (Suprefact), 0.5cc subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was started 14 days thereafter.

Patients were categorized according to the following stimulation protocols:

Group A (control group): which 300 IU r-FSH was administered for the first 5 days of the stimulation cycle. Then the first ultrasound scan was performed to monitor response. At this stage the dose of rFSH adjusted according to the ovarian response and continued until the day of ovulatory hCG administration.

Group B: rFSH supplemented with daily administration of 100 IU hCG in the late follicular phase based on the follicle size (14mm).

Group C: rFSH supplemented with daily administration of 200 IU hCG in the late follicular phase based on the follicle size (14mm).

To assess the pregnancy outcomes, serum hCG was measured 2 weeks after embryo transfer. Clinical pregnancy was defined by the observation of sac with fetal heart rate on ultrasonography 4 weeks after embryo transfer.

  Eligibility

Ages Eligible for Study:   37 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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)
  2. indication for ICSI treatment, second or third cycle
  3. Age 37 to 43 years
  4. Body mass index (BMI) ≤ 30 kg/m2
  5. The presence of two functional ovaries and no previous ovarian surgery
  6. The presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation
  7. Basal (day 2 or 3) serum FSH levels ≤13 IU/L
  8. Normal semen analysis
  9. No history or signs of endometriosis
  10. No untreated endocrinologic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509833

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Tahereh Madani, MD scientist
Principal Investigator: Ladan Mohmmadi yeganeh, MSc scientist
  More Information

No publications provided by Royan Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01509833     History of Changes
Other Study ID Numbers: Royan-Emb-013
Study First Received: January 5, 2012
Last Updated: January 10, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
ICSI Ovarian stimulation
hCG low dose
Oocyte maturity
poor respond

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013