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Patients who have received 25 IU gonadotropin dose increment on 7th day of ovulation induction

Patients who have received 25 IU gonadotropin dose increment on 14th day of ovulation induction

Gonadotropin dose increments of 25 IU will be utilized on 7th and 14th day of ovulation induction for each study group.

Gonadotropin dose increment timing

Serkan Kahyaoglu, M.D

Inci Kahyaoglu, M.D

Omer H Yumusak, M.D

Berna Seckin, M.D

Hacer C Gulerman, M.D

Muzeyyen G Ozaksit, M.D

Ozlem Moraloglu Tekin, M.D

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.

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.

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

Number of \>14 mm sized follicles at the end of the ovulation induction treatment

Serum pregnancy test will be performed 2 weeks after ovulation triggering

Clinical pregnancy rate which will be evaluated 3 weeks after ovulation triggering

Total number of ovulation induction days until ovulation triggering

Cycle cancellation due to \>=3 preovulatory follicles (\>14 mm in size) at the end of the ovulation induction treatment

Multiple pregnancy rate which will be evaluated 3 weeks after ovulation triggering

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT04528849	Polycystic Ovar... Infertility, Fe...	Gonadotropin do...	21 Years - 39 Years	Saglik Bilimleri Universitesi
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	NCT04528849	Polycystic Ovar... Infertility, Fe...	Gonadotropin do...	21 Years - 39 Years	Saglik Bilimleri Universitesi

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