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CompletedNCT03174691Updated Aug 6, 2019

Early Luteal Progesterone Profile in IVF Patients Triggered With hCG

An interventional study of Blood collection in Infertility, sponsored by Vietnam National University. Completed at 1 site in Vietnam. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Vietnam National University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
161
Allocation
Not applicable
Ages
18 Years to 42 Years
Sex
Female
01

Study 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.

Read the detailed description

The early luteal phase after IVF treatment is only scarcely studied. During IVF treatment the early luteinizing hormone (LH) activity deficit induced after ovarian stimulation with exogenous gonadotropins will be partly covered by the bolus of hCG used for triggering of final oocyte maturation due to the long half-life of hCG. In addition, the luteal phase will be covered by exogenous progesterone supplementation. After successful implantation the embryo itself will provide the supportive LH activity, securing the function of the corpora lutea. However, during the early luteal phase and peri-implantation, recent data suggest that an early-mid-luteal hCG/LH deficiency exists after hCG trigger during which the corpus luteum lacks an optimal stimulation. Furthermore, the early luteal progesterone profile in IVF differs significantly from the progesterone profile of the natural cycle, in which the peak is reached around the time of implantation. With this non-invasive trial, we wish to further explore the early luteal phase profiles of progesterone, 17-Hydroxyprogesterone and hCG in order to optimize current luteal phase support policies in IVF and hopefully increase ongoing pregnancy rates.

02

Conditions studied

  • Infertility

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03

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
161 participants (actual)

Study arms

  • Experimental
    Hormonal levels

    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

  • Diagnostic testBlood collection

    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.

05

What researchers measure

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.

    Time frame: In 6 days after human chorionic gonadotropin injection

Secondary outcomes

  1. Number of follicles ≥ 11 mm luteal phase

    Number of follicles are counted by ultrasound.

    Time frame: On the day of hCG injection

06

Study locations

1 site
  • My Duc Hospital
    Ho Chi Minh City, 70000, Vietnam
07

References and documents

Publications

  • 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. PubMed 31967304 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03174691
Lead sponsor
Vietnam National University
Collaborators
Mỹ Đức Hospital
Responsible party
Manh Tuong Ho (Doctor, Vietnam National University) — Principal investigator
First posted
Jun 2, 2017
Start date
Jun 7, 2017
Primary completion
Aug 8, 2017
Completion
Aug 8, 2017
Last update
Aug 6, 2019

Study contacts

Tuong M Ho, MD
principal investigator · Research Center for Genetics and Reproductive Health Ho Chi Minh, Ho Chi Minh Vietnam

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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