Early Luteal Progesterone Profile After hCG Triggering

NCT02798146 | Completed

• 1 other identifier: NCKH/CGRH -01-2016
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.

Conditions

Infertility

Keywords

in-vitro fertilization; luteal phase

Outcome Measures

Primary Outcomes (4)

• change in serum concentrations of progesterone

  Blood samples are collected at ten points of time.

  in 6 days after human chorionic gonadotropin injection

• change in serum concentrations of luteinizing hormone

  Blood samples are collected at ten points of time.

  in 6 days after hCG injection

• change in serum concentrations of estradiol

  Blood samples are collected at ten points of time.

  in 6 days after hCG injection

• change in serum concentrations of hCG

  Blood samples are collected at ten points of time.

  in 6 days after hCG injection

Secondary Outcomes (1)

• number of follicles larger than 11 millimeters

  on the day of hCG injection

Study Arms (1)

hormonal levels

OTHER

Blood samples are collected for analysis of LH, E2, hCG and progesterone.

Other: blood collection

Interventions

blood collection OTHER

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

hormonal levels

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• IVF patients who meet the following criteria:
• Freeze all cycle after hCG trigger
• Age 18 - 38
• Body Mass Index (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 Gonadotropin Releasing Hormone 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 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.

Sponsors & Collaborators

• Vietnam National University: lead
• Mỹ Đức Hospital: collaborator

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: 31967304 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 5, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: April 11, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share