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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528849
• Other study ID #: E1-20-377
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: August 20, 2022

Study information

• Verified date: August 2020
• Source: Saglik Bilimleri Universitesi
• Contact: Serkan Kahyaoglu, M.D
• Phone: +905058868040
• Email: serkan.kahyaoglu[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 20, 2022
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Ankara City Hospital, Department of Reproductive Endocrinology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of preovulatory follicles	Number of >14 mm sized follicles at the end of the ovulation induction treatment	35 days
Secondary	Biochemical pregnancy rate	Serum pregnancy test will be performed 2 weeks after ovulation triggering	2 weeks after ovulation triggering
Secondary	Clinical pregnancy rate	Clinical pregnancy rate which will be evaluated 3 weeks after ovulation triggering	3 weeks after ovulation triggering
Secondary	Cycle length in days	Total number of ovulation induction days until ovulation triggering	7-35 days
Secondary	Cycle cancellation	Cycle cancellation due to >=3 preovulatory follicles (>14 mm in size) at the end of the ovulation induction treatment	35 days
Secondary	Multiple pregnancy rate	Multiple pregnancy rate which will be evaluated 3 weeks after ovulation triggering	3 weeks after ovulation triggering

External Links

•   Improved monofollicular ovulation in anovulatory or oligo-ovulatory women after a low-dose step-up protocol with weekly increments of 25 international units of follicle-stimulating hormone
•   Ovulation induction with a starting dose of 50 IU of recombinant follicle stimulating hormone in WHO group II anovulatory women: the IO-50 study, a prospective, observational, multicentre, open trial
•   Pilot study of the optimal protocol of low dose step-up follicle stimulating hormone therapy for infertile women