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

Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation

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.

Study Overview

• Status: Completed
• Conditions: Endocrine System Diseases; Gonadal Disorders
• Intervention / Treatment: Drug: low dose human chorionic gonadotropin; Drug: Clomiphen citrate plus HMG

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan institute, Reproductive Medicine Research Centre, ACECR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low dose hCG group	Drug: low dose human chorionic gonadotropin; patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate; Other Names: human chorionic gonadotropin
ACTIVE_COMPARATOR: Clomiphen citrate plus HMG	Drug: Clomiphen citrate plus HMG; patients will receive Clomiphen Citrate plus HMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Multiple pregnancy rates, OHSS rate	Within 20 months after recruiting

Secondary Outcome Measures

Outcome Measure	Time Frame
Pregnancy rate	Within 20 months after recruiting
The total dose of ovarian stimulation drugs	Within 20 months after recruiting
The number of embryos available for transfer	Within 20 months after recruiting
The embryo implantation rate and The live birth rate	Within 20 months after recruiting

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Principal Investigator: Mahnaz Ashrafi, Royan institute, Reproductive Medicine Research Centre, ACECR

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: July 25, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (ESTIMATE): July 28, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 15, 2011
• Last Update Submitted That Met QC Criteria: July 14, 2011
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Polycystic Ovary Syndrome; Clomiphene citrate; Human chorionic gonadotropin; chronic anovulation; Follicolugenesis
• Additional Relevant MeSH Terms: Neoplasms; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Polycystic Ovary Syndrome; Endocrine System Diseases; Gonadal Disorders; Physiological Effects of Drugs; Reproductive Control Agents; Chorionic Gonadotropin
• Other Study ID Numbers: Royan-Emb-002