Clinical trial · Interventional

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

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

NCT02523898CI-TRIAL-00076475terminatedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): unfortunately due to COVID 19and social problems following it,we were unable to reach the estimated sample size.Evantually we could have only 151 patients .

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hyperandrogenism	—	UNRESOLVED	—
Polycystic Ovary Syndrome	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
clomiphene citrate	Drug	—	UNRESOLVED
metformine	Drug	Metformin	ALIAS
placebo	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
metformine and clomiphene citrate
description
. 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.
interventionNames
1. Drug: metformine
2. Drug: clomiphene citrate
type
ACTIVE_COMPARATOR
label
placebo and clomiphene citrate
description
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). .

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 20 Years
Maximum age: 36 Years

Show eligibility criteria text

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.

References

Publications (45)

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