Clinical trial NCT00947713: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Endocrine System Diseases
Gonadal Disorders
Keywords: Human chorionic gonadotropin
Clomiphene citrate
chronic anovulation
Polycystic Ovary Syndrome
Follicolugenesis
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2009-07-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Multiple pregnancy rates, OHSS rate
timeFrame: Within 20 months after recruiting
Secondary outcomes:
measure: Pregnancy rate
timeFrame: Within 20 months after recruiting
measure: The total dose of ovarian stimulation drugs
timeFrame: Within 20 months after recruiting
measure: The number of embryos available for transfer
timeFrame: Within 20 months after recruiting
measure: The embryo implantation rate and The live birth rate
timeFrame: Within 20 months after recruiting
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan institute, Reproductive Medicine Research Centre, ACECR
Study officials:
affiliation: Royan institute, Reproductive Medicine Research Centre, ACECR
name: Mahnaz Ashrafi
role: PRINCIPAL_INVESTIGATOR
References: