Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles

January 7, 2021 updated by: Barbara Lawrenz, ART Fertility Clinics LLC

Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles for IVF/ICSI, in Hormonal Replacement Cycles and Natural Cycles for Frozen Embryo Transfer

This study will measure the blood flow in the aa. uterinae in women, undergoing firstly ovarian stimulation for In-Vitro Fertilization (IVF) / Intracytoplasmic sperm injection (ICSI), in Hormonal Replacement cycles (HRT) and Natural cycles (NC) for Frozen Embryo Transfer (FET)

Study Overview

Status

Completed

Conditions

Detailed Description

To evaluate the influence of ovarian stimulation on the blood flow in the arteriae uterinae as well as whether there is an influence of the type of endometrial preparation for FET with either hormonal replacement therapy or natural cycle on the blood flow of the arteria uterina left / right

Study Type

Observational

Enrollment (Actual)

124

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with primary / secondary infertility, who undergo an ovarian stimulation treatment for IVF/ICSI and subsequently are planned for FET with vitrified embryos, either as HRT-FET or as NC-FET

Description

Inclusion Criteria:

  • Patients who undergo ovarian stimulation in a Gonadotropin-Releasing-Hormone (GnRH)-antagonist protocol for IVF / ICSI
  • Patients who have vitrified embryo(s)
  • Preparation for FET either in HRT or NC cycle

Exclusion Criteria:

  • Poor responder according to Bologna criteria (Ferraretti et al.) as follows:
  • At least two of the following three features must be present:
  • (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian reserve (POR);
  • (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol);
  • (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles or anti-mullerian hormone (AMH) 0.5 -1.1 ng/ml).
  • Uterine surgery for removal of fibroids (hysteroscopic, laparoscopic) or removal of uterine septum
  • Endometriosis
  • Asherman-Syndrome
  • Previous cytotoxic treatment
  • Previous radiation of the uterus / adnexal region
  • Known hypertension
  • Intake of Aspirin or similar medication which might influence the blood flow
  • Status after tubal ligation
  • Status after surgery in the adnexal region on 1 side

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
Artificial (HRT) Cycles
  1. Commence estradiol tablets (E2) 4mg from day 2 or 3 of period for 3 days
  2. Increase E2 to 6mg on day 4 of E2 treatment, according to clinician discretion based on endometrial thickness.
  3. Transvaginal scan throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of a dominant follicle on the ovaries.
  4. Serial measurements of serum LH (luteinizing hormone), estradiol and progesterone levels.
  5. Initial progesterone dose of 100mg at 22hrs (vaginal suppository) after ≥ 10 days and ≤ 16 days of estradiol administration when the minimal endometrial thickness achieved is 6mm with a trilaminar appearance.
  6. Subsequently increase progesterone administration to 100mg vaginally three times daily. Continue E2 administration 6mg (3 tablets daily). Embryo transfer is scheduled 5 days following the initial initiation of progesterone
Spontaneous natural cycles
  1. Day 2 of menses and throughout patients' natural cycle scans to monitor follicular growth.
  2. Measurements of serum LH, estradiol and progesterone levels to determine ovulation.
  3. The LH surge will be considered to have begun when the concentration rises by 180% above the most recent serum value and continues to rise thereafter (Irani et al. 2017, Fatemi et al., 2010).
  4. Day 1 after the LH rise, a decrease in estradiol concentration is identified. Twenty four hours later progesterone concentrations rise with a level of greater than or equal to 1.5nmol /L confirming ovulation (day 0) (Irani et al., 2017; Speroff et al.). This is considered as day 0 with initiation of vaginal progesterone 100mg at 22hrs that night. The following day (day 1) the patient increases progesterone administration to 100mg vaginally 8 hourly and continues until 7 weeks gestation as per clinic protocol. Embryo transfer is scheduled 5 days (day 5) following confirmation of ovulation (day 0).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles
Time Frame: 1 day
On the day of progesterone administration / progesterone rise. Quantitative continuous variable
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous quantitative variable measured as the differences between average PI value
Time Frame: 1 day
On the day of cycle start and the day of ovulation induction. Continuous quantitative variable measured in millimeters (mm)
1 day
Continuous quantitative variable measured as the differences between average RI value
Time Frame: 2 days
On the day of cycle start and the day of ovulation induction
2 days
Thickness of the lining
Time Frame: 1 day
Continuous quantitative variable measured in millimeters (mm)
1 day
Number of days of estradiol exposure
Time Frame: 1 day
Before the embryo transfer
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: Barbara Lawrenz, PhD, IVI RMA Abu Dhabi

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)

April 23, 2019

Primary Completion (Actual)

September 26, 2020

Study Completion (Actual)

December 14, 2020

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1901-ABU-002-BL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Endometrial Receptivity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe