An interventional study of Gonadotropin dose increment timing in Polycystic Ovary Syndrome and Infertility, Female, sponsored by Saglik Bilimleri Universitesi. Status unknown at 1 site in Turkey. Open to female participants aged 21 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment
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.
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Inclusion Criteria: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.
Exclusion Criteria: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.
Patients who have received 25 IU gonadotropin dose increment on 7th day of ovulation induction
Drug: Gonadotropin dose increment timing
Patients who have received 25 IU gonadotropin dose increment on 14th day of ovulation induction
Drug: Gonadotropin dose increment timing
Gonadotropin dose increments of 25 IU will be utilized on 7th and 14th day of ovulation induction for each study group.
Number of preovulatory follicles
Number of \>14 mm sized follicles at the end of the ovulation induction treatment
Time frame: 35 days
Biochemical pregnancy rate
Serum pregnancy test will be performed 2 weeks after ovulation triggering
Time frame: 2 weeks after ovulation triggering
Clinical pregnancy rate
Clinical pregnancy rate which will be evaluated 3 weeks after ovulation triggering
Time frame: 3 weeks after ovulation triggering
Cycle length in days
Total number of ovulation induction days until ovulation triggering
Time frame: 7-35 days
Cycle cancellation
Cycle cancellation due to \>=3 preovulatory follicles (\>14 mm in size) at the end of the ovulation induction treatment
Time frame: 35 days
Multiple pregnancy rate
Multiple pregnancy rate which will be evaluated 3 weeks after ovulation triggering
Time frame: 3 weeks after ovulation triggering
Plan to share: No
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Saglik Bilimleri Universitesi