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


Phase 1/Phase 2
18 Years
30 Years
Not Enrolling
Female
Endocrine System Diseases, Gonadal Disorders

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Multiple pregnancy rates, OHSS rate

Outcome Time Frame:

Within 20 months after recruiting

Safety Issue:

Yes

Principal Investigator

Mahnaz Ashrafi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royan institute, Reproductive Medicine Research Centre, ACECR

Authority:

Iran: Ministry of Health

Study ID:

Royan-Emb-002

NCT ID:

NCT00947713

Start Date:

August 2009

Completion Date:

December 2010

Related Keywords:

  • Endocrine System Diseases
  • Gonadal Disorders
  • Human chorionic gonadotropin
  • Clomiphene citrate
  • chronic anovulation
  • Polycystic Ovary Syndrome
  • Follicolugenesis
  • Anovulation
  • Endocrine System Diseases
  • Gonadal Disorders
  • Polycystic Ovary Syndrome

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