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Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome

Primary Purpose

Endocrine System Diseases, Gonadal Disorders

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
low dose human chorionic gonadotropin
Clomiphen citrate plus HMG
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endocrine System Diseases focused on measuring Human chorionic gonadotropin, Clomiphene citrate, chronic anovulation, Polycystic Ovary Syndrome, Follicolugenesis

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with PCOS diagnosed by the Rotterdam criteria
  • Previously documented dominant follicle or follicles (R12 mm mean diameter) on transvaginal Ultrasound follicular monitoring while receiving CC at the 150-mg dose in our clinic but have failed to ovulate;
  • Primary infertility
  • Documented normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy;
  • Male partner had to have a normal semen analysis by World Health Organization criteria.

Exclusion Criteria:

  • previous history of IVF or ICSI treatments.
  • History of hormonal treatment within recent three month (Except OCP, progesterone).
  • History of ovarian cutter or Ovarian drilling.
  • BMI higher than 30.
  • The presence of ovarian cyst (more than 30 mm) during third cycle ultrasound.

Sites / Locations

  • Royan institute, Reproductive Medicine Research Centre, ACECR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low dose hCG group

Clomiphen citrate plus HMG

Arm Description

Outcomes

Primary Outcome Measures

Multiple pregnancy rates, OHSS rate

Secondary Outcome Measures

Pregnancy rate
The total dose of ovarian stimulation drugs
The number of embryos available for transfer
The embryo implantation rate and The live birth rate

Full Information

First Posted
July 25, 2009
Last Updated
July 14, 2011
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00947713
Brief Title
Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome
Official Title
Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the effectiveness of low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its endocrine response in patients who had previously failed to ovulate on clomiphen citrate alone. The investigators will also compare the effectiveness and endocrine response of this approach with the regimen of adding HMG to clomiphen citrate.
Detailed Description
Infertile women with PCOS, who have showed resistance to Clomiphen Citrate (150 mg- 5 days) in a previous IUI treatment cycle at Royan Institute (Infertility and Reproductive Medicine Research Centre) will enroll in this prospective randomized clinical trial study and will randomly be divided into three groups. The study protocol will be assessed by an independent institutional review board and Royan ethics committee. All subjects will be given the written informed consent. Control group (CC/hMG) will receive the 100 mg CC on days 3 to 7 of that cycle but will receive 150 mg human menopausal gonadotropin (HMG) during days of 7, 8, and 9. One of experimental Group (group B) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when the largest follicle is 12 mm or larger mean diameter. Other experimental group (Group C) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9(without attention to follicle size). In both experimental groups HCG administration will be continued until the largest follicle is 18-20 mm. Ultrasound measurements of follicle number and growth, ovulation, gestational sac, and serum hormonal levels will be recorded and compared between two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine System Diseases, Gonadal Disorders
Keywords
Human chorionic gonadotropin, Clomiphene citrate, chronic anovulation, Polycystic Ovary Syndrome, Follicolugenesis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose hCG group
Arm Type
Experimental
Arm Title
Clomiphen citrate plus HMG
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
low dose human chorionic gonadotropin
Other Intervention Name(s)
human chorionic gonadotropin
Intervention Description
patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate
Intervention Type
Drug
Intervention Name(s)
Clomiphen citrate plus HMG
Intervention Description
patients will receive Clomiphen Citrate plus HMG
Primary Outcome Measure Information:
Title
Multiple pregnancy rates, OHSS rate
Time Frame
Within 20 months after recruiting
Secondary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
Within 20 months after recruiting
Title
The total dose of ovarian stimulation drugs
Time Frame
Within 20 months after recruiting
Title
The number of embryos available for transfer
Time Frame
Within 20 months after recruiting
Title
The embryo implantation rate and The live birth rate
Time Frame
Within 20 months after recruiting

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with PCOS diagnosed by the Rotterdam criteria Previously documented dominant follicle or follicles (R12 mm mean diameter) on transvaginal Ultrasound follicular monitoring while receiving CC at the 150-mg dose in our clinic but have failed to ovulate; Primary infertility Documented normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy; Male partner had to have a normal semen analysis by World Health Organization criteria. Exclusion Criteria: previous history of IVF or ICSI treatments. History of hormonal treatment within recent three month (Except OCP, progesterone). History of ovarian cutter or Ovarian drilling. BMI higher than 30. The presence of ovarian cyst (more than 30 mm) during third cycle ultrasound.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahnaz Ashrafi
Organizational Affiliation
Royan institute, Reproductive Medicine Research Centre, ACECR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan institute, Reproductive Medicine Research Centre, ACECR
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.royaninstitute.org
Description
Related Info

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Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome

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