NCT04602143

Brief Summary

This study compared the therapeutic effect of 4- and 6-week TTG application before controlled ovarian hyperstimulation (COH) in POR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 16, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

2.4 years

First QC Date

October 20, 2020

Last Update Submit

October 20, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    The main outcomes of our study were the total number of retrieved

    30 minutes after oocyte retrieval complete

Secondary Outcomes (3)

  • Pregnancy rates.

    14 days after embryo transfer

  • clinical pregnancy rates.

    4 weeks after embryo transfer

  • Ongoing pregnancy rates

    after 12 weeks of gestation

Study Arms (3)

Testosterone gel 4 weeks

EXPERIMENTAL

Patients with low ovarian reserve received 4-week TTG application before controlled ovarian hyperstimulation.

Drug: Testosterone gel

Testosterone gel 6 weeks

EXPERIMENTAL

Patients with low ovarian reserve received 6-week TTG application before controlled ovarian hyperstimulation.

Drug: Testosterone gel

Control group

NO INTERVENTION

Patients with low ovarian reserve received no medication before controlled ovarian hyperstimulation.

Interventions

Testosterone gelDRUG

Apply 12.5mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 4 or 6 weeks until next IVF treatment.

Also known as: Androgel 1% Transdermal Gel
Testosterone gel 4 weeksTestosterone gel 6 weeks

Eligibility Criteria

Age20 Years - 47 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having one previous IVF/ intracytoplasmic sperm injection (ICSI) cycle with ≤ 3 oocytes recruited.
  • AFC ≤ 5 - 7.
  • Anti-Mullerian hormone (AMH) ≤ 0.5 - 1.1 ng/mL.

You may not qualify if:

  • donated gamete IVF cycles
  • Thyroid disease
  • Liver and kidney dysfunction
  • Abnormal genitalia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanoi Medical University, Vietnam

Hanoi, 250000, Vietnam

Location

MeSH Terms

Conditions

Infertility

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Hung S Ho, MD, PhD

    Hanoi Medical University

    STUDY DIRECTOR

  • Tien V Nguyen, MD, PhD

    Hanoi Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participantes are not aware of treatment groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 26, 2020

Study Start

February 16, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)