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

NCT02523898 | Terminated Phase 2 DMC

• 1 other identifier: SemnanUMS1
• Study Type: interventional
• Target: 388
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism

Keywords

Clomiphene; infertility; insuline resistant; metformine; PCOS

Outcome Measures

Primary Outcomes (1)

• ovulation rate

  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.

  every other weeks up to 8 weeks

Secondary Outcomes (2)

• Clinical pregnancy rate

  5 weeks of gestation

• Ongoing pregnancy rate

  12 weeks of gestation

Study Arms (2)

metformine and clomiphene citrate

EXPERIMENTAL

. 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; Drug: clomiphene citrate

placebo and clomiphene citrate

ACTIVE COMPARATOR

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; Drug: clomiphene citrate

Interventions

metformine DRUG

1500 mg metformine 8week plus 100 mg clomiphene for 5 days

Also known as: Glucophage,Glumetza

metformine and clomiphene citrate

placebo DRUG

placebo 8 weeks plus 100 mg clomiphene for 5 days

Also known as: placebo,identical to metformine, sugar pill manufactured to mimic metformine 500mg

placebo and clomiphene citrate

clomiphene citrate DRUG

100 mg clomiphene for 5 days starting from day 3 of their spontaneous menses or withdrawal bleeding induced by progestin administration

Also known as: clomid,serophene

metformine and clomiphene citrate; placebo and clomiphene citrate

Eligibility Criteria

• Age: 20 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semnan University of Medical Sciences: lead

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  PMID: 19910321 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism; Infertility

Interventions

Metformin; Sugars; Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Carbohydrates; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• 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

  Abnormal Uterine Bleeding Research Center, Semnan University of Medical Sciences, Semnan, Iran.

  PRINCIPAL INVESTIGATOR

• Majid Mirmohammadkhani, Phd

  Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Infertility ward.

Study Record Dates

• First Submitted: July 11, 2015
• First Posted: August 14, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 25, 2024

Record last verified: 2024-04