A Proof of Concept Study of Serum Progesterone Levels for IVF/ICSI Following HCG Trigger for Oocyte Maturation

February 17, 2022 updated by: ART Fertility Clinics LLC

A Proof of Concept Study to Determine the Rise of Progesterone Levels After Human Chorionic Gonadotrophin (hCG) Trigger in Stimulated Cycles of IVF/ICSI

This study will determine the rise of progesterone levels after human chorionic gonadotrophin (hCG) trigger in stimulated cycles IVF/ICSI

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies have suggested that controlled ovarian hyperstimulation adversely affects endometrial receptivity. In ovarian stimulation cycles with exogenous gonadotrophins there is an ongoing debate regarding the effect of a late follicular phase progesterone level on reproductive outcomes. It is not yet clarified if an elevated serum progesterone level in the late follicular phase is a symptom or cause of an adverse effect on reproductive outcomes. A new hypothesis is evolving and gaining momentum providing a novel explanation for the association between late follicular phase progesterone rise and reproductive outcome. It is proposed that exogenous FSH (Follicle-stimulating hormone) administration results in supraphysiological levels of FSH, which induce an abundance of LH (luteinizing hormone) receptors on granulosa cells causing the follicles to become hypersensitive to LH-like activity (ie hCG trigger). Based on this hypothesis, the focus should be placed on the hCG trigger rather than on the late follicular phase progesterone rise.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients who are planned to commence ovarian stimulation for IVF/ICSI with hCG trigger for oocyte maturation and plan to avail of pre-implantation genetic screening with embryo vitrification of their biopsied embryos at blastocyst stage

Description

Inclusion Criteria:

  • Females aged 18 to 42 years with regular menstrual cycles of 26-34 days
  • Undergoing ovarian stimulation for IVF/ICSI & PGS.
  • Receiving recombinant FSH for stimulation
  • hCG 5000iu IM as trigger injection for oocyte maturation.
  • Ovarian stimulation in GnRH-antagonist protocols
  • BMI 18- 35 kg/m2
  • Having 1 or 2 euploid embryos for transfer in spontaneous natural cycles.

Exclusion Criteria:

  • Poor ovarian reserve as defined by Bologna criteria
  • PCOS in accordance with Rotterdam criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
stimulated cycles
Patients will have blood drawn on five separate occasions: before and following hCG trigger on the day of final oocyte maturation and day of egg collection
Drug: hCG
human chorionic gonadotropin
Other Names:
  • human chorionic gonadotropin
Diagnostic test: Ultrasound
Endometrial thickness monitoring
Other Names:
  • transvaginal scan
Other: Blood test
Progesterone, Luteinizing Hormone, Estradiol
Other Names:
  • Progesterone, Luteinizing Hormone, Estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of progesterone day of trigger
Time Frame: 1 day
day of the hCG trigger between 1000h - 1200h, before trigger, 1 hour after trigger, 2 hrs after trigger
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of progesterone day of egg retrieval
Time Frame: 1 day
36hrs after trigger
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Raquel Loja Vitorino, Specialist, ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 4, 2021

Primary Completion (ACTUAL)

May 26, 2021

Study Completion (ACTUAL)

June 30, 2021

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002-ABU-001-CC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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