NCT04528849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2022

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

Same day

First QC Date

August 24, 2020

Last Update Submit

August 24, 2020

Conditions

Polycystic Ovary SyndromeInfertility, Female

Keywords

Polycystic ovary syndromeInfertilityLow dose step-upGonadotropinOvulation induction

Outcome Measures

Primary Outcomes (1)

  • Number of preovulatory follicles

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

    35 days

Secondary Outcomes (5)

  • Biochemical pregnancy rate

    2 weeks after ovulation triggering

  • Clinical pregnancy rate

    3 weeks after ovulation triggering

  • Cycle length in days

    7-35 days

  • Cycle cancellation

    35 days

  • Multiple pregnancy rate

    3 weeks after ovulation triggering

Study Arms (2)

Early dose increment

ACTIVE COMPARATOR

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

Drug: Gonadotropin dose increment timing

Late dose increment

ACTIVE COMPARATOR

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

Drug: Gonadotropin dose increment timing

Interventions

Gonadotropin dose increment timingDRUG

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

Early dose incrementLate dose increment

Eligibility Criteria

Age21 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Ankara City Hospital, Department of Reproductive Endocrinology

Ankara, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Serkan Kahyaoglu, M.D

    Ankara City Hospital, Department of Reproductive Endocrinology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serkan Kahyaoglu, M.D

CONTACT

+905058868040serkan.kahyaoglu@sbu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 27, 2020

Study Start

August 20, 2020

Primary Completion

August 20, 2020

Study Completion

August 20, 2022

Last Updated

August 27, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)