NCT03725280

Brief Summary

The effects of gender transitioning, particularly the effects of testosterone exposure in transgender men, on the oocyte and embryo development are largely unknown. Based on prior studies suggesting that the extracellular RNAs secreted by the ovarian follicle cells reflect the oocyte and embryo biological state, the investigators propose to use these extracellular RNAs to gain insights into the effects of testosterone exposure in transgender men on their oocyte and embryo without impacting the clinical IVF process.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

October 4, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

October 4, 2018

Last Update Submit

October 27, 2018

Conditions

IVFFertility PreservationInfertility

Keywords

Micro RNAOvarian Follicular fluidTransgender menTestosterone

Outcome Measures

Primary Outcomes (1)

  • Characterization of micro RNA profile in follicle fluid of transgender men treated with testosterone.

    The follicle fluid of transgender men will be collected during egg retrieval, and micro RNA will be isolated from the follicle fluid samples using The Norgen and The ExoRNeasy methods (followed by qRT-PCR validation) and subjected to RNA sequencing analysis using NEBNext multiple small RNAseq library preparation kits. Total Testosterone levels (ng/ml) in the blood will be examined in all patients prior to the IVF treatment.

    5 years

Secondary Outcomes (4)

  • The association between micro RNA profile in follicle fluid of transgender men and the number of eggs.

    5 years

  • The association between micro RNA profile in follicle fluid of transgender men and the maturation level of the eggs.

    5 years

  • The association between micro RNA profile in follicle fluid of transgender men and the embryo quality.

    5 years

  • The association between micro RNA profile in follicle fluid of transgender men and the embryo development level.

    5 years

Study Arms (4)

Transgender men I

Transgender men after testosterone treatment

Procedure: IVF

Transgender men II

Transgender men before testosterone treatment

Procedure: IVF

IVF- PCOS

IVF- PCOS patients with high testosterone levels

Procedure: IVF

Egg donors

IVF- egg donors patients

Procedure: IVF

Interventions

IVFPROCEDURE

None interventional study (Collection of ovarian follicular fluid during IVF treatment)

Also known as: not interventional study
Egg donorsIVF- PCOSTransgender men ITransgender men II

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale undergoing IVF treatments for fertility preservation/infertility/egg donation
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Transgender men before testosterone therapy Transgender men after testosterone therapy, Patients with polycystic ovarian syndrome (PCOS) and high testosterone levels undergoing IVF treatments Egg donors undergoing IVF treatments

You may qualify if:

  • \* Patients aged 18 and older.

You may not qualify if:

  • Patients under 18 years old.
  • Patients who did not respond to hormone therapy and the IVF cycle was discontinued.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research & Development Director

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 31, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2021

Study Completion

November 1, 2023

Last Updated

October 31, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share