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

Sponsor

Saglik Bilimleri Universitesi (Other)

Overall Status

Unknown status

CT.gov ID

NCT04528849

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Infertility, Female	Drug: Gonadotropin dose increment timing	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 20, 2020

Actual Primary Completion Date :

Aug 20, 2020

Anticipated Study Completion Date :

Aug 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Early dose increment Patients who have received 25 IU gonadotropin dose increment on 7th 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.
Active Comparator: Late dose increment 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.

Arm

Intervention/Treatment

Active Comparator: Early dose increment

Patients who have received 25 IU gonadotropin dose increment on 7th 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.

Active Comparator: Late dose increment

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.

Outcome Measures

Primary Outcome Measures

Number of preovulatory follicles [35 days]
Number of >14 mm sized follicles at the end of the ovulation induction treatment

Secondary Outcome Measures

Biochemical pregnancy rate [2 weeks after ovulation triggering]
Serum pregnancy test will be performed 2 weeks after ovulation triggering
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
Cycle cancellation [35 days]
Cycle cancellation due to >=3 preovulatory follicles (>14 mm in size) at the end of the ovulation induction treatment
Multiple pregnancy rate [3 weeks after ovulation triggering]
Multiple pregnancy rate which will be evaluated 3 weeks after ovulation triggering

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 39 Years

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.