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

January 5, 2012
January 10, 2012
October 2009
March 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01509833 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection
Efficacy of Low Dose hCG on Oocyte Maturity for Ovarian Stimulation in Poor Responder Women Undergoing ICSI: a Prospective Randomized Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • Drug: rFSH
    Administration of rFSH for ovarian stimulation.
  • Drug: hCG
    Administration of late follicular low dose hCG(100IU) for ovarian stimulation.
  • Drug: hCG
    Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
  • Experimental: rFSH
    Administration of recombinant FSH for ovarian stimulation.
    Intervention: Drug: rFSH
  • Experimental: hCG(100IU)
    Administration of late follicular low dose hCG(100U) for ovarian stimulation.
    Intervention: Drug: hCG
  • Experimental: hCG(200IU)
    Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
    Intervention: Drug: hCG
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
December 2011
March 2011   (final data collection date for primary outcome measure)

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
Female
37 Years to 43 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01509833
Royan-Emb-013
Yes
Royan Institute
Royan Institute
Not Provided
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Tahereh Madani, MD scientist
Principal Investigator: Ladan Mohmmadi yeganeh, MSc scientist
Royan Institute
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP