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
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| ClinicalTrials.gov Identifier: NCT04528849 |
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Recruitment Status :
Recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Polycystic Ovary Syndrome Infertility, Female | Drug: Gonadotropin dose increment timing | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | August 20, 2020 |
| Actual Primary Completion Date : | August 20, 2020 |
| Estimated Study Completion Date : | August 20, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Early dose increment
Patients who have received 25 IU gonadotropin dose increment on 7th day of ovulation induction
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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. |
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Active Comparator: Late dose increment
Patients who have received 25 IU gonadotropin dose increment on 14th day of ovulation induction
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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 [ Time Frame: 35 days ]Number of >14 mm sized follicles at the end of the ovulation induction treatment
- Biochemical pregnancy rate [ Time Frame: 2 weeks after ovulation triggering ]Serum pregnancy test will be performed 2 weeks after ovulation triggering
- Clinical pregnancy rate [ Time Frame: 3 weeks after ovulation triggering ]Clinical pregnancy rate which will be evaluated 3 weeks after ovulation triggering
- Cycle length in days [ Time Frame: 7-35 days ]Total number of ovulation induction days until ovulation triggering
- Cycle cancellation [ Time Frame: 35 days ]Cycle cancellation due to >=3 preovulatory follicles (>14 mm in size) at the end of the ovulation induction treatment
- Multiple pregnancy rate [ Time Frame: 3 weeks after ovulation triggering ]Multiple pregnancy rate which will be evaluated 3 weeks after ovulation triggering
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| Ages Eligible for Study: | 21 Years to 39 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528849
| Contact: Serkan Kahyaoglu, M.D | +905058868040 | serkan.kahyaoglu@sbu.edu.tr |
| Turkey | |
| University of Health Sciences, Ankara City Hospital, Department of Reproductive Endocrinology | Recruiting |
| Ankara, Turkey | |
| Contact: Serkan Kahyaoglu, M.D +905058868040 serkan.kahyaoglu@sbu.edu.tr | |
| Principal Investigator: Serkan Kahyaoglu, M.D | |
| Sub-Investigator: Inci Kahyaoglu, M.D | |
| Sub-Investigator: Omer H Yumusak, M.D | |
| Sub-Investigator: Berna Seckin, M.D | |
| Sub-Investigator: Hacer C Gulerman, M.D | |
| Sub-Investigator: Muzeyyen G Ozaksit, M.D | |
| Sub-Investigator: Ozlem Moraloglu Tekin, M.D | |
| Principal Investigator: | Serkan Kahyaoglu, M.D | Ankara City Hospital, Department of Reproductive Endocrinology |
| Responsible Party: | Serkan Kahyaoglu, Associate Professor, M.D, Saglik Bilimleri Universitesi |
| ClinicalTrials.gov Identifier: | NCT04528849 |
| Other Study ID Numbers: |
E1-20-377 |
| First Posted: | August 27, 2020 Key Record Dates |
| Last Update Posted: | August 27, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Polycystic ovary syndrome Infertility Low dose step-up Gonadotropin Ovulation induction |
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Polycystic Ovary Syndrome Infertility Infertility, Female Syndrome Disease Pathologic Processes Ovarian Cysts |
Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |