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Trial record 77 of 107 for:    "21-hydroxylase deficiency"

Metformine and CC Compared With Placebo and CC for Induction Ovulation in PCOS Patients With Insulin Resistant

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ClinicalTrials.gov Identifier: NCT02523898
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2015
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Azam Azargoon, Semnan University of Medical Sciences

Brief Summary:
Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility which affects 12-21% of the population.Several studies performed evaluate the possible benefit of metformin alone or in combination with clomiphene (CC)as first-line treatment for infertility in women with PCOS have reported conflicting results. These conflicting results may be due to the presence or absence of insulin resistance(IR).Metformin decreases IR .However there is not a single randomized clinical trial with metformin in IR PCOS patients. Therefore, the aim of current study is to compare CC with coadministration of metformin and with CC with coadministration of placebo in IR PCOS patients to induce ovulation.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Hyperandrogenism Drug: metformine Drug: placebo Drug: clomiphene citrate Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is the Co-administration of Metformine and CC as Compared to Placebo and CC Superior to Induce Ovulation in PCOS Patients With a Confirmed insulin-resistant-a Double Blind Randomized Clinical Trial
Study Start Date : November 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: metformine and clomiphene citrate
. metformin will be given at a dose of 500 mg three times a day for 8weeks. .In case of failure of ovulation after the end of this period, metformin was continued and patients were given 100 mg clomiphene for 5 days starting from day 3 of their spontaneous menses or withdrawal bleeding induced by progestin administration In cases of ovulation with CC without pregnancy, the patients were advised to participate in other two similar cycles of therapy with 100 mg clomiphene. When ovulation did not occur with 100 mg CC, its dose will be increased to 150 mg and the same treatment protocol will be used for this dose.
Drug: metformine
1500 mg metformine 8week plus 100 mg clomiphene for 5 days
Other Name: Glucophage,Glumetza

Drug: clomiphene citrate
100 mg clomiphene for 5 days starting from day 3 of their spontaneous menses or withdrawal bleeding induced by progestin administration
Other Name: clomid,serophene

Active Comparator: placebo and clomiphene citrate

The patients in group two will be receiving placebo. In case of failure of ovulation after the end of this period, placebo was continued and patients were given 100 mg clomiphene for 5 days starting from day 3 of their spontaneous menses or withdrawal bleeding induced by progestin administration .In cases of ovulation with CC without pregnancy, the patients were advised to participate in other two similar cycles of therapy with 100 mg clomiphene.When ovulation did not occur with 100 mg CC, its dose will be increased to 150 mg and the same treatment protocol will be used for this dose. .

10 days). .

Drug: placebo
placebo 8 weeks plus 100 mg clomiphene for 5 days
Other Names:
  • placebo,identical to metformine
  • sugar pill manufactured to mimic metformine 500mg

Drug: clomiphene citrate
100 mg clomiphene for 5 days starting from day 3 of their spontaneous menses or withdrawal bleeding induced by progestin administration
Other Name: clomid,serophene




Primary Outcome Measures :
  1. ovulation rate [ Time Frame: every other weeks up to 8 weeks ]
    The progesterone levels will be measured every other week in order to document ovulation. A progesterone level > 5 ng/ml (16 nmol per liter) will considered as confirmatory of ovulation during metformine administration .Ovarian follicular response will be monitored by transvaginal sonography every other day from day 10 of the cycle to the 16th day of the cycle.ovulation will be confrmed When at least one follicle reached ≥18 mm in diameter.


Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 5 weeks of gestation ]
    Clinical pregnancy will be defined as the detection of at least one gestational sac on transvaginal ultrasound examination starting one week after the missed period

  2. Ongoing pregnancy rate [ Time Frame: 12 weeks of gestation ]
    Ongoing pregnancy will be defined as the detection of an alive fetus>12weeks of gestation on transvaginal ultrasound examination.



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Ages Eligible for Study:   20 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Insulin resistant ( HOMA-IR≥2.3) PCOS women between 20-36 years of age, with period of infertility more than 1 year and normal serum prolactin ,normal TSH after treatment , normal hystero salpingography and had no other infertility factor.

The diagnosis of PCOS according to the Rotterdam Criteria.

Exclusion Criteria:

  • Diabetic women
  • Any medication that could influence carbohydrate metabolism or pituitary-gonadal function at least 2 months before the study
  • Hypertension or abnormal renal or liver function tests
  • Ovarian drilling.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523898


Sponsors and Collaborators
Semnan University of Medical Sciences
Investigators
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Principal Investigator: Human M Fatemi, MD Director GCC-Operations | Nova IVI Fertility LLC .Royale Marina Office, B22-23 P.O. 60202.Abu Dhabi/UAE
Principal Investigator: Azam Azargoon, MD Research center of Abnormal Uterine Bleeding and Department of Infertility, Amir-AL-Momenin Hospital, Semnan University of Medical Sciences, Semnan, Iran
Principal Investigator: Majid Mirmohammadkhani, Phd Research Center for Social Determinants of Health, Department of Community Medicine, Faculty of, Semnan University of Medical Sciences, Semnan, Iran.

Additional Information:
Publications of Results:
Other Publications:
Speroff L, Fritz MA. Induction ovulation In :Cilinical gynecologic endocrinology and infertility. 7th Ed. Philadelphi: Lippincott,Williams and Wilkins; 2005: 499-1180.

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Responsible Party: Azam Azargoon, Director of Infertility ward., Semnan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02523898     History of Changes
Other Study ID Numbers: SemnanUMS1
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Keywords provided by Azam Azargoon, Semnan University of Medical Sciences:
Clomiphene
infertility
insuline resistant
metformine
PCOS
Additional relevant MeSH terms:
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Adrenogenital Syndrome
Polycystic Ovary Syndrome
Hyperandrogenism
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Metformin
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Progestins
Hypoglycemic Agents
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists