NCT05220995

Brief Summary

PGS has been the most effective method for embryo selection in IVF cycles. Euploidy rates decrease significantly with advancing maternal age (AMA). The dosage of gonadotropins also may be increased to recruit an adequate number of follicles in AMA women, minimal Stimulation Protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) for controlled ovarian hyperstimulation is defined for poor ovarian response women. The aim of this study is to show minimal stimulation protocol affect euploidy and pregnancy rates in preimplatation genetic screening (PGS) cycles with single embryo transfer.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

May 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

January 31, 2022

Last Update Submit

January 31, 2022

Conditions

Keywords

preimplantation genetic screeninggonadotropin dosageeuploidy rates

Outcome Measures

Primary Outcomes (1)

  • euploid rates

    the effects of different stimulation protocols on euploid rates

    3 months

Secondary Outcomes (1)

  • pregnancy rates

    3 months

Study Arms (2)

100 patients with minimal

In advancing maternal age (AMA) women, minimal stimulation protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women.

Genetic: protocol

100 patients with recombinant FSH antagonist protocol

In advancing maternal age (AMA) women, flexible antagonist protocol with recombinant FSH were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women.

Genetic: protocol

Interventions

protocolGENETIC

ovarian stimulation protocols on euploid rates were compared.

100 patients with minimal100 patients with recombinant FSH antagonist protocol

Eligibility Criteria

Age38 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmore than 38 years old
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

200 advanced maternal aged women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gokalp Oner

Kayseri, Gevher Nesibe, 38039, Turkey (Türkiye)

NOT YET RECRUITING

Gokalp Oner

Kayseri, Gevher Nesibe, 38039, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

embryo

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Adem Yavuz

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 2, 2022

Study Start

May 15, 2021

Primary Completion

January 23, 2022

Study Completion

January 25, 2022

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

We can not share.

Locations