Early Luteal Hormones and IVF Outcomes After hCG Triggering

NCT04693624 | Completed

• 1 other identifier: 18/20/DD-BV
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

It has recently been demonstrated that a bolus trigger of hCG induces various unphysiological conditions in the early luteal phase that may negatively affect an IVF treatment cycle's reproductive outcome. The bolus trigger of hCG differ from the natural cycle in mainly three different ways: 1) The timing of the initiation of hCG and progesterone rise is much faster after an hCG trigger than in the natural menstrual cycle 2) the maximal concentrations of hCG and progesterone considerably exceed those naturally observed 3) The timing of the peak progesterone concentration following an hCG trigger is advanced several days compared to the natural cycle. These characteristics may affect the reproductive outcome in treatment cycles but are not explored. The aim of this study is to monitor whether specific trajectories of important luteal phase hormones may predict the chances of conception?

Conditions

Luteal Phase; in Vitro Fertilisation

Outcome Measures

Primary Outcomes (3)

• Live birth rate in relation to the trajectory of progesterone in the early luteal phase

  Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count).

  After 24 weeks of gestation

• Live birth rate in relation to the trajectory of 17-OH progesterone in the early luteal phase

  Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count).

  After 24 weeks of gestation

• Live birth rate in relation to the trajectory of hCG in the early luteal phase

  Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count).

  After 24 weeks of gestation

Secondary Outcomes (7)

• The clinical pregnancy rate in relation to the trajectory of progesterone in the early luteal phase

  At 5 weeks after embryo placement

• The ongoing pregnancy rate in relation to the trajectory of progesterone in the early luteal phase

  At 10 weeks or beyond after the embryo placement

• The clinical pregnancy rate in relation to the trajectory of 17-OH progesterone in the early luteal phase

  At 5 weeks after embryo placement

• The ongoing pregnancy rate in relation to the trajectory of 17-OH progesterone in the early luteal phase

  At 10 weeks or beyond after the embryo placement

• The miscarriage rate in relation to the trajectory of progesterone in the early luteal phase

  Before 12 weeks of gestation

Study Arms (1)

Hormonal levels

Blood samples are collected for analysis of progesterone, hCG, inhibin-A, and 17-OH-Progesterone levels.

Other: Hormonal levels

Interventions

Hormonal levels OTHER

A total of ten (10) blood samples (2ml/each) will be collected during the study for subsequent analysis of progesterone, hCG, inhibin-A, and 17-OH-progesterone: Day of triggering (before the injection of hCG, appx. 6 pm) Twelve (12 hours) after hCG injection (appx. at 6 am) Twenty-four (24) hours after hCG injection (appx. at 6 pm) Thirty-six (36) hours after hCG injection (appx. at 8 am, 2 hours after OPU) One (1) day after OPU (60h after hCG) (appx. at 6 am) Two (2) days after OPU (84h after hCG) (appx. at 6 am) Three (3) days after OPU 108h after hCG) (appx. at 6 am) Four (4) days after OPU (132h after hCG) (appx. at 6 am) Five (5) days after OPU (156h after hCG) (appx. at 6 am) Six (6) days after OPU (180h after hCG) (appx. at 6 am)

Hormonal levels

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Vietnamese women who will be indicated for IVF treatment with hCG administration for final oocytes maturation and undergo fresh embryo transfers.

You may qualify if:

• Age 18 - 38
• BMI \< 28kg/m2
• Normal ovarian reserve (anti-Müllerian hormone level above 8.93 pmol/L or an antral follicle count of 6 or above within two months prior to stimulation)
• Having 4 to 19 follicles with a diameter of 14mm or above on the day of hCG triggering
• Receiving a standard GnRH-antagonist protocol for ovarian stimulation
• Having indication for fresh embryo transfer
• Willingness to participate in the study, and to disclose any medical conditions to the investigator. The patient must be prepared and willing to comply with the requirements of the protocol.
• The patient should after appropriate oral and written consent understand the study and be informed that she may withdraw consent at any time without prejudice to future medical care.

You may not qualify if:

• Previous poor ovarian response (≤ 3 follicles) after appropriate FSH stimulation
• Hyper-response defined as ≥20 follicles ≥14 mm on the day of trigger
• Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B, Sexually Transmitted Diseases and simultaneous participation in an interventional clinical trial.

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

Location

Related Publications (1)

• N Vuong L, D Pham T, N A Ho V, T L Vu A, M Ho T, Yding Andersen C. In vitro fertilization outcome based on the detailed early luteal phase trajectory of hormones: a prospective cohort study. Reprod Biol Endocrinol. 2024 May 20;22(1):56. doi: 10.1186/s12958-024-01229-3.

  PMID: 38769552 DERIVED

Study Officials

• Lan N Vuong, PhD

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: January 12, 2021
• Primary Completion: August 30, 2022
• Study Completion: January 31, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)