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
- Conditions
- Infertility, FemalePolycystic Ovary Syndrome
- Interventions
- Drug: Gonadotropin dose increment timing
- Registration Number
- NCT04528849
- Lead Sponsor
- Saglik Bilimleri Universitesi
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 160
Infertile women who have been diagnosed with PCOS based on Rotterdam criteriae and who have not succeeded to get pregnant by using oral ovulation induction agents and whose BMI levels are <30 kg/m2 will be included to the study.
Infertile women with tubal diseases, male factor infertility, endometriosis, previous pelvic surgery history, chronic systemic disease, BMI levels>30 kg/m2 and who are not voluntary to attend to the study will be excluded from the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Early dose increment Gonadotropin dose increment timing Patients who have received 25 IU gonadotropin dose increment on 7th day of ovulation induction Late dose increment Gonadotropin dose increment timing Patients who have received 25 IU gonadotropin dose increment on 14th day of ovulation induction
- Primary Outcome Measures
Name Time Method Number of preovulatory follicles 35 days Number of \>14 mm sized follicles at the end of the ovulation induction treatment
- Secondary Outcome Measures
Name Time Method Biochemical pregnancy rate 2 weeks after ovulation triggering Serum pregnancy test will be performed 2 weeks after ovulation triggering
Multiple pregnancy rate 3 weeks after ovulation triggering Multiple pregnancy rate which will be evaluated 3 weeks after ovulation triggering
Cycle cancellation 35 days Cycle cancellation due to \>=3 preovulatory follicles (\>14 mm in size) at the end of the ovulation induction treatment
Clinical pregnancy rate 3 weeks after ovulation triggering Clinical pregnancy rate which will be evaluated 3 weeks after ovulation triggering
Cycle length in days 7-35 days Total number of ovulation induction days until ovulation triggering
Trial Locations
- Locations (1)
University of Health Sciences, Ankara City Hospital, Department of Reproductive Endocrinology
🇹🇷Ankara, Turkey