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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00947713
Other study ID # Royan-Emb-002
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received July 25, 2009
Last updated July 14, 2011
Start date August 2009
Est. completion date December 2010

Study information

Verified date April 2010
Source Royan Institute
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Drug:
low dose human chorionic gonadotropin
patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate
Clomiphen citrate plus HMG
patients will receive Clomiphen Citrate plus HMG

Locations

Country Name City State
Iran, Islamic Republic of Royan institute, Reproductive Medicine Research Centre, ACECR Tehran

Sponsors (1)

Lead Sponsor Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Multiple pregnancy rates, OHSS rate Within 20 months after recruiting Yes
Secondary Pregnancy rate Within 20 months after recruiting No
Secondary The total dose of ovarian stimulation drugs Within 20 months after recruiting No
Secondary The number of embryos available for transfer Within 20 months after recruiting No
Secondary The embryo implantation rate and The live birth rate Within 20 months after recruiting No
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