Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome (MIP)

Ain Shams University

Status and phase: Completed; Early Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02498522

Metformin in pregnancy

Details and patient eligibility

About

The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS).

Full description

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive age (12-45 years old) and is thought to be one of the leading causes of the female subfertility

• The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with PCOS
• Research question:

In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss?

-Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early pregnancy loss.

Enrollment: 166 patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age : 25 - 35.

• Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )

  • At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination.
  • Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations.
  • Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking.

• Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.

Exclusion criteria

• patients with other causes of infertility other than PCOS
• contraindications to metformin : liver impairment , renal failure.
• Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups, including a placebo group

metformin arm

Experimental group

Description:

83 patients will continue metformin until end of 1st trimester (14 weeks gestation)

Treatment:

Drug: Metformin

control arm

Placebo Comparator group

Description:

83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)

Treatment:

Drug: Metformin