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

Sponsor:	Royan Institute
Information provided by:	Royan Institute
ClinicalTrials.gov Identifier:	NCT00947713

Purpose

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.

Condition	Intervention	Phase
Endocrine System Diseases Gonadal Disorders	Drug: low dose human chorionic gonadotropin Drug: Clomiphen citrate plus HMG	Phase I Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation

Resource links provided by NLM:

MedlinePlus related topics: Endocrine Diseases

Drug Information available for: Clomiphene citrate Zuclomiphene Enclomiphene Menotropins Citric acid Choriogonadotropin Alfa Clomiphene Sodium Citrate trans-Clomifene citrate Chorionic gonadotropin

U.S. FDA Resources

Further study details as provided by Royan Institute:

Primary Outcome Measures:

Multiple pregnancy rates, OHSS rate [ Time Frame: Within 20 months after recruiting ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pregnancy rate [ Time Frame: Within 20 months after recruiting ] [ Designated as safety issue: No ]
The total dose of ovarian stimulation drugs [ Time Frame: Within 20 months after recruiting ] [ Designated as safety issue: No ]
The number of embryos available for transfer [ Time Frame: Within 20 months after recruiting ] [ Designated as safety issue: No ]
The embryo implantation rate and The live birth rate [ Time Frame: Within 20 months after recruiting ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low dose hCG group: Experimental	Drug: low dose human chorionic gonadotropin patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate
Clomiphen citrate plus HMG: Active Comparator	Drug: Clomiphen citrate plus HMG patients will receive 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.

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947713

Contacts

Contact: Nasser Aghdami, MD., PhD

(98) 2122402486

nasser.aghdami@royaninstitute.org

Locations

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

Sponsors and Collaborators

Royan Institute

Investigators

Principal Investigator:

Mahnaz Ashrafi

Royan institute, Reproductive Medicine Research Centre, ACECR

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Royan institute ( Hamid Gourabi, Chief )
Study ID Numbers:	Royan-Emb-002
Study First Received:	July 25, 2009
Last Updated:	August 1, 2009
ClinicalTrials.gov Identifier:	NCT00947713 History of Changes
Health Authority:	Iran: Ministry of Health

Keywords provided by Royan Institute:

Human chorionic gonadotropin
Clomiphene citrate
chronic anovulation
Polycystic Ovary Syndrome
Follicolugenesis

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Hormone Antagonists
Physiological Effects of Drugs
Hematologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Clomiphene
Ovarian Diseases
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Chorionic Gonadotropin
Genital Diseases, Female
Estrogen Receptor Modulators
Therapeutic Uses

Menotropins
Estrogen Antagonists
Anticoagulants
Citric Acid
Endocrine System Diseases
Cysts
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Fertility Agents, Female
Fertility Agents
Polycystic Ovary Syndrome
Chelating Agents
Ovarian Cysts

ClinicalTrials.gov processed this record on February 04, 2010