Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates

April 20, 2023 updated by: Heli Alexandroni, Shaare Zedek Medical Center

Prospective Randomized Control Study of Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates

The aim of the study is to compare the pregnancy rate between women treated with Gonadotropin Releasing Hormone (GnRH) agonist together with Human Chorionic Gonadotropin (HCG) and standard luteal support with progesterone following transfer of frozen embryos in in-vitro-fertilization (IVF) natural cycles.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The rate of frozen embryos transfer (FET) has increased in recent years due to a higher tendency of single embryo transfer, use of preimplantation genetic testing, and prevention of ovarian hyperstimulation.

There are different methods to prepare the endometrium for FET:

  1. Natural cycle (NC) - natural preparation of the body for implantation without the need for medicinal intervention.
  2. Modified natural cycle (mNC) - Inducing ovulation by administration of Human Chorionic Gonadotropin (HCG) trigger.
  3. Medical - preparation of endometrium with hormones (estrogen and progesterone).

Following embryo transfer, luteal phase support should be considered. Administration of treatment depends on the type of cycle chosen (either natural or medicated). Treatment options include progesterone, HCG and Gonadotropin Releasing Hormone (GnRH) analog - either one of them or combined. Different protocols (dosages and duration of use) with different pregnancy outcomes were explore before with inconclusive results. We wish to investigate administration of GnRH agonist+HCG vs. progesterone.

Patients included in the study will be women undergoing natural cycle FET at the IVF center in Shaare Zedek, Jerusalem, Israel. All patients will be randomly divided into two groups, each will receive a different luteal treatment support as will be detailed later. Patients demographic data and pregnancy outcomes will be collected.

Based on the clinical pregnancy rate in the prospective study by Bjuresten, et al [Fertil Steril, 2011], where a clinical pregnancy rate of 32% was found among women treated with progesterone for luteal support, and given an alpha of 5% and a power of 80%, 144 women (72 women in each group) are required in order to demonstrate a clinical pregnancy rate of 55% in the study group.

Comparison of categorical variables will be carried out using the the chi-squared test. Comparison of continuous variables will be performed using the Students t-Test or Mann-Whitney U method depending on the variable distribution (normal vs. non-normal distribution, respectively). A multivariate regression will also be conducted in order to determine which variables are significantly and independently related. Statistical significance will be defined when P values are less than 0.05

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Normo-ovulatory women
  • Women undergoing frozen embryos transfer in a natural cycle
  • Age 18-45
  • BMI 18-35

Exclusion Criteria:

  • Women undergoing medicated frozen embryos transfer
  • Women with a BMI over 35 or under 18.
  • Women with hydrosalpinges
  • Women with defects or uterine malformations (congenital) or acquired such as myomas
  • Egg donation and surrogacy
  • Use of preimplantation genetic testing

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group

Patients will receive luteal support with GNRH agonist and HCG according to departmental protocol:

Cleavage stage embryo:

  • ET day (embryo day 2-3) - Ovitrelle 125mcg
  • Day 3 after ET - Ovitrelle 125mcg + Decapeptyl 0.1mg
  • Day 6 after ET- Ovitrelle 125mcg
  • Day 9 after ET - Ovitrelle 125mcg

Embryo blastocyst stage:

  • ET day (embryo day 5-6) - Ovitrelle 125mcg + Decapeptyl 0.1mg
  • Day 3 after ET - Ovitrelle 125mcg
  • Day 6 after ET - Ovitrelle 125mcg
Drug: GnRH agonist
125 mcg once at the day mentioned
Drug: hCG
dose as mentioned
Active Comparator: Control group
Patients will receive luteal support with vaginal progesterone - 100 mg Endometrin twice daily until week 8 of pregnancy.
Drug: Progesterone 100Mg Vag Tab
dose as mentioned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: up to two month after embryo transfer
visualization of intrauterine gestational sac on ultrasound divided by number of transfers
up to two month after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall pregnancy rate
Time Frame: up to two month after embryo transfer
number positive beta-hCG divided by total number of transfers
up to two month after embryo transfer
Implantation rate
Time Frame: up to two month after embryo transfer
number of gestational sacs divided by number of embryos transferred
up to two month after embryo transfer
Ectopic pregnancy rate
Time Frame: up to two month after embryo transfer
number of ectopic pregnancy divided by number of positive beta-hCG
up to two month after embryo transfer
Miscarriage rate
Time Frame: up to 20 weeks after embryo transfer
number of non-viable before 24 weeks divided by total number of positive beta-hCG
up to 20 weeks after embryo transfer
Live birth rate
Time Frame: up to 42 weeks after embryo transfer
number of live births after 24 weeks divided by number of transfers.
up to 42 weeks after embryo transfer

Collaborators and Investigators

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

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Keren Rotshenker Olshnika, MD, Sharee Zedek Medical Center, Israel

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)

October 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LutealSupport

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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