Recruiting NA Metformin

New treatment option for Metformin

Official title Effect of Metformin on Healthy Live Birth in Women With Prediabetes

ClinicalTrials.gov ID: NCT06064669

What this study is testing

What is Metformin pretreatment before ovarian stimulation?

Metformin pretreatment before ovarian stimulation is an investigational medicine, given as an once-daily, being studied as a potential treatment for metformin.

Also referred to as Metformin before ovarian stimulation.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.
  • You might receive a placebo (an inactive treatment) instead of the study drug.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 20 to 40, women only. Healthy volunteers may be eligible.

You may be able to join if

  • Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.
  • Women aged 20-40 years.
  • Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.

You likely can't join if

  • Women who are diagnosed with diabetes according to the ADA criteria11,12, which is meeting one of the following criteria: fasting plasma glucose...
  • Women who are taking medicine that interfere with glucose metabolism, such as metformin, oral anti-diabetic agents (sulfonylureas, glinides...
  • Women with un-corrected hyperthyroidism or hypothyroidism.
  • Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.
  • Women with a diagnosis of adenomyosis.
  • Women with untreated hydrosalpinx.
See the full eligibility criteria
Who can join
  • Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.
  • Women aged 20-40 years.
  • Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.
What rules you out
  • Women who are diagnosed with diabetes according to the ADA criteria11,12, which is meeting one of the following criteria: fasting plasma glucose ≥7.0mmol/L, 2-h plasma glucose during 75-g OGTT ≥11.1mmol/L, HbA1c≥6.5%...
  • Women who are taking medicine that interfere with glucose metabolism, such as metformin, oral anti-diabetic agents (sulfonylureas, glinides, thiazolidinediones, α-glycosidase inhibitors, GLP-1 receptor agonist, etc.)...
  • Women with un-corrected hyperthyroidism or hypothyroidism.
  • Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.
  • Women with a diagnosis of adenomyosis.
  • Women with untreated hydrosalpinx.
  • Women who plan to undergo PGT-SR or PGT-M.
  • Women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.

The study team makes the final eligibility decision.

Where it's taking place

  • Jinan, Shandong, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 20 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.