NCT06234540

Brief Summary

This study sought to compare the endometrial thickness among infertile women with a history of thin endometrium together with previous cancellation from IVF/ICSI inspection of intrauterine instillation of autologous-PRP or no treatment before embryo transfer in the frozen-thaw cycles.

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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 23, 2024

Last Update Submit

January 30, 2024

Conditions

Thin Endometrium

Keywords

PRP, Platelet-rich plasma, IVF/ICSI, Frozen Thaw cycle

Outcome Measures

Primary Outcomes (1)

  • endometrial thickness

    compare endometrial thickness among 3 group

    day 12

Secondary Outcomes (5)

  • endometrial thickness difference between day 8 and day 12

    between day 8 and day 12

  • clinical pregnancy rate

    12 weeks

  • chemical pregnancy rate

    2 weeks after transfer

  • miscarriage rate

    up to 12 weeks

  • cancellation rate

    day 14

Study Arms (3)

aPRP 1

EXPERIMENTAL

a-PRP intrauterine instillation on Menstruation Cycle Day 8 during frozen thaw cycle procedure

Procedure: PRP

aPRP 2

EXPERIMENTAL

a-PRP intrauterine instillation on Menstruation Cycle Day 8 and Day 10 during frozen thaw cycle procedure

Procedure: PRP

Controlled

EXPERIMENTAL

Standard treatment of frozen thaw cycle

Other: Standard treatment

Interventions

PRPPROCEDURE

a-PRP intrauterine instillation before frozen-thawed embryo transfer cycle

aPRP 1aPRP 2
Standard treatmentOTHER

Standard treatment

Controlled

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsinfertile woman
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo frozen embryo transfer (Frozen-thawed cycle)
  • Age above 18 years
  • Thai nationality
  • Have a history of cycle cancellation due to a thin endometrium \<7 mm. after standard hormonal treatmetn

You may not qualify if:

  • medical conditions eg. Platelet dysfunction , vWD
  • thrombocytopenia \<100,000 cell/mm3
  • Receive antiplatelet therapy
  • Uterine anomaly, cavity distortion eg submucous myoma uteri, uterine synergia, endometrial polyp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Study Officials

  • Sootthinan Pothisan

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sootthinan Pothisan

CONTACT

0894600852sootthinan.pot@gmail.com

Nichamon Parkpinyo

CONTACT

0867632251ni_nichamon@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Infertility unit, Obstetric and gynecology department of Siriraj hospital, Mahidol university

Study Record Dates

First Submitted

January 23, 2024

First Posted

January 31, 2024

Study Start

January 21, 2024

Primary Completion

January 31, 2025

Study Completion

May 31, 2025

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

TH(1)