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NCT Number: NCT06775093

Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity

The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.

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Key information

About this study

Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with a wish to conceive; Women with PCOS (Rotterdam criteria); 28 kg/m2≤BMI<35kg/m2;

Exclusion criteria

Women with medical morbidity; Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine anomalies or untreated tubal hydrosalpinx; Receiving a donor oocyte or donor sperm cycle; Chromosome abnormality or recurrent miscarriage; planning preimplantation genetic testing (PGT); Any other contraindications to fertility treatment; Allergic to or contraindicated for GLP-1 class medications.

Treatment and study plan

GLP-1 receptor agonist

Drug

3 months

Other names: Benaglutide

metformin

Drug

3 months

Healthy Lifestyle Education

Behavioral

3 months

Primary outcomes

  1. Live birth rate

    Time frame: 18 months

Secondary outcomes

  1. BMI change from baseline to the 3rd month in kg/m2

    Time frame: 3 months

  2. Spontaneous resumption of ovulation

    Time frame: 3 months

  3. Clinical pregnancy

    Time frame: 9 months

  4. Ongoing pregnancy

    Time frame: 11 months

  5. Pregnancy loss

    Time frame: 18 months

  6. Gestational age at delivery

    Time frame: 18 months

  7. Time to pregnancy leading to live birth

    Time frame: 18 months

  8. Hypertensive disorders of pregnancy

    Time frame: 18 months

  9. Gestational diabetes

    Time frame: 18 months

  10. Birth weight in kg

    Time frame: 18 months

  11. Neonatal mortality

    Time frame: 18 months

  12. Major congenital anomaly

    Time frame: 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Shuo Huang

CONTACT

[email protected]

+861082266699

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Effects of GLP-1 Receptor Agonists Combined with Metformin and Healthy Lifestyle Education Prior to Fertility Treatment on Reproductive Outcomes in Women with PCOS and Obesity

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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