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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
rFSH
hCG
hCG
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring ICSI Ovarian stimulation, hCG low dose, Oocyte maturity, poor respond

Eligibility Criteria

37 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

rFSH

hCG(100IU)

hCG(200IU)

Arm Description

Administration of recombinant FSH for ovarian stimulation.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of retrieved oocytes
Evaluation the number of retrieved oocytes Up to 1 hour after oocyte retrieval
Number of generated embryos
Evaluation the number of generated embryos up to 48-72 hours after oocyte retrieval.
Quality of generated embryos
Evaluation the Quality of generated embryos up to 48-72 hours after oocyte retrieval.
Number of transferred embryos
Evaluation the number of transferred embryos on the time of embryo transfer.
Quality of transferred embryos
Evaluation the quality of transferred embryos on the time of embryo transfer.
implantation rate
Evaluation the implantation rate 4 weeks after embryo transfer.
chemical pregnancy rates
Evaluation the chemical pregnancy rates 2 weeks after embryo transfer.
clinical pregnancy rates
Evaluation the clinical pregnancy rates 4 weeks after embryo transfer.

Full Information

First Posted
January 5, 2012
Last Updated
January 10, 2012
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01509833
Brief Title
Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection
Official Title
Efficacy of Low Dose hCG on Oocyte Maturity for Ovarian Stimulation in Poor Responder Women Undergoing ICSI: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ICSI Ovarian stimulation, hCG low dose, Oocyte maturity, poor respond

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rFSH
Arm Type
Experimental
Arm Description
Administration of recombinant FSH for ovarian stimulation.
Arm Title
hCG(100IU)
Arm Type
Experimental
Arm Description
Administration of late follicular low dose hCG(100U) for ovarian stimulation.
Arm Title
hCG(200IU)
Arm Type
Experimental
Arm Description
Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
Intervention Type
Drug
Intervention Name(s)
rFSH
Intervention Description
Administration of rFSH for ovarian stimulation.
Intervention Type
Drug
Intervention Name(s)
hCG
Intervention Description
Administration of late follicular low dose hCG(100IU) for ovarian stimulation.
Intervention Type
Drug
Intervention Name(s)
hCG
Intervention Description
Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
Primary Outcome Measure Information:
Title
Number of mature oocytes
Description
Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval
Time Frame
Up to 2 hours after oocyte retrieval
Secondary Outcome Measure Information:
Title
Number of retrieved oocytes
Description
Evaluation the number of retrieved oocytes Up to 1 hour after oocyte retrieval
Time Frame
Up to 1 hour after oocyte retrieval
Title
Number of generated embryos
Description
Evaluation the number of generated embryos up to 48-72 hours after oocyte retrieval.
Time Frame
Up to 48-72 hours after oocyte retrieval
Title
Quality of generated embryos
Description
Evaluation the Quality of generated embryos up to 48-72 hours after oocyte retrieval.
Time Frame
Up to 48-72 hours after oocyte retrieval
Title
Number of transferred embryos
Description
Evaluation the number of transferred embryos on the time of embryo transfer.
Time Frame
on the time of embryo transfer
Title
Quality of transferred embryos
Description
Evaluation the quality of transferred embryos on the time of embryo transfer.
Time Frame
on the time of embryo transfer
Title
implantation rate
Description
Evaluation the implantation rate 4 weeks after embryo transfer.
Time Frame
4 weeks after embryo transfer
Title
chemical pregnancy rates
Description
Evaluation the chemical pregnancy rates 2 weeks after embryo transfer.
Time Frame
2 weeks after embryo transfer
Title
clinical pregnancy rates
Description
Evaluation the clinical pregnancy rates 4 weeks after embryo transfer.
Time Frame
4 weeks after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tahereh Madani, MD
Organizational Affiliation
scientist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ladan Mohmmadi yeganeh, MSc
Organizational Affiliation
scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22956348
Citation
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.
Results Reference
derived

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

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