NCT03174691

Brief Summary

Until now very little information exists regarding the early luteal serum progesterone profile after Human chorionic gonadotropin (hCG) trigger. This pilot study will help characterize the serum progesterone, 17-hydroxyprogesterone profiles in IVF patients and correlate progesterone, 17-Hydroxyprogesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

June 7, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2017

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

May 30, 2017

Last Update Submit

August 3, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Serum concentrations of progesterone,17-Hydroxyprogesterone, LH, E2, and hCG during early luteal phase

    Blood samples are collected at ten points of time.

    In 6 days after human chorionic gonadotropin injection

Secondary Outcomes (1)

  • Number of follicles ≥ 11 mm luteal phase

    On the day of hCG injection

Study Arms (1)

Hormonal levels

EXPERIMENTAL

Collect blood samples Blood samples are collected on the following days after human chorionic gonadotropin (hCG) injection: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6

Diagnostic Test: Blood collection

Interventions

Blood collectionDIAGNOSTIC_TEST

A total of ten (10) blood samples (2ml/each) will be collected during the study. Blood samples will be collected on the following days for subsequent analysis of LH, Estradiol, hCG, progesterone and 17-Hydroxyprogesterone.

Hormonal levels

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Freeze all cycle after hCG trigger
  • Age 18 - 38
  • BMI \< 28kg/m2
  • Normal ovarian reserve, defined by Anti-Mullerian Hormone (AMH) \> 1.25 ng/ml or Antral Follicle Count (AFC) ≥ 6 measured within two months prior to stimulation start
  • Receiving gonadotrophin releasing hormone (GnRH) antagonist co-treatment during ovarian stimulation
  • Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
  • Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

You may not qualify if:

  • Previous poor response (≤ 3 oocytes) after high dose follicle stimulating hormone (FSH) stimulation
  • Hyper-response defined as \>20 follicles ≥ 14 mm
  • Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (1)

  • Vuong LN, Ho TM, Pham TD, Ho VNA, Andersen CY, Humaidan P. The early luteal hormonal profile in IVF patients triggered with hCG. Hum Reprod. 2020 Jan 1;35(1):157-166. doi: 10.1093/humrep/dez235.

    PMID: 31967304DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Tuong M Ho, MD

    Research Center for Genetics and Reproductive Health Ho Chi Minh, Ho Chi Minh Vietnam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: IVF patients triggered with hCG
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 2, 2017

Study Start

June 7, 2017

Primary Completion

August 8, 2017

Study Completion

August 8, 2017

Last Updated

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)