Comparison of Ovulation Induction Cycle Outcomes Between Early and Late Dose Increments for Low Dose Gonadotropin Step-up Protocol Among Infertile Women Diagnosed With Polycystic Ovary Syndrome: Prospective Randomised Trial

Last updated: August 24, 2020
Sponsor: Saglik Bilimleri Universitesi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Infertility

Reproductive Health

Treatment

N/A

Clinical Study ID

NCT04528849
E1-20-377
  • Ages 21-39
  • Female
  • Accepts Healthy Volunteers

Study Summary

Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome (PCOS). First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with PCOS.

Eligibility Criteria

Inclusion

Inclusion Criteria:Infertile women who have been diagnosed with PCOS based on Rotterdamcriteriae and who have not succeeded to get pregnant by using oral ovulation inductionagents and whose BMI levels are <30 kg/m2 will be included to the study.

Exclusion

Exclusion Criteria:Infertile women with tubal diseases, male factor infertility,endometriosis, previous pelvic surgery history, chronic systemic disease, BMI levels>30kg/m2 and who are not voluntary to attend to the study will be excluded from the study.

Study Design

Total Participants: 160
Study Start date:
August 20, 2020
Estimated Completion Date:
August 20, 2022

Study Description

Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome. First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with polycystic ovary syndrome.

We will start low dose step-up ovulation induction treatment by using 50 IU recombinant FSH for 21-39 years old non- obese patients (BMI <30 kg/m2) diagnosed with PCOS and . We will perform folliculometry on 7th day of ovulation induction. In case of absence for at least one >10 mm dominant follicle, we will randomise these women by using blind envelope selection method for assignment of early or late dose incerement groups. Half of the patients will receive 25 IU dose increment on 7th day of ovulation induction, remaining half will receive dose increment on 14th day of ovulation induction. We will continue ovarian stimulation without any other dose increment until 35th day of stimulation as deadline time restriction. We will perform folliculometry and serum estradiol measurement intermittently during ovulation induction. We will record ovulation induction cycle outcomes and clinical pregnancy results of the study group following finalization for treatment cyle of each patient. We will compare ovulation induction cycle outcomes of these two dose increment groups.

Connect with a study center

  • University of Health Sciences, Ankara City Hospital, Department of Reproductive Endocrinology

    Ankara,
    Turkey

    Active - Recruiting

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