Natural Cycle Versus Stimulated Cycle Before Frozen Embryo Transfer (SONTEC)

February 5, 2019 updated by: Dr Massin Nathalie

Comparison of the Number of Visits and the Quality of Life Versus Natural Cycle in Stimulated Cycle Before Frozen Embryo Transfer

Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of infertility. This method is performed in presence of supernumerary embryo(s) after fresh transfer, or after freeze all embryos in case of medical reasons. It is necessary to control that the transfer is performed when the endometrium is receptive, which is essential for embryo implantation and pregnancy. This period is defined as the "implantation window". Endometrial preparation can be achieved by hormone replacement therapy (HRT) or moderate ovarian stimulation (SO). The implantation window can also be assessed by monitoring of a natural cycle (NC). The objectives of this open randomized study is to compare the number of visits (ultrasound and blood tests) induced by the SO or NC as well as the women quality of life in both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For infertile couples supported by in vitro fertilization, embryo freezing is a technique used regularly to optimize the pregnancy rate per retrieval of oocytes. This method is performed in case of supernumerary embryo(s) after fresh embryo transfer, or freeze all of the embryonic cohort in case of medical reasons preventing the transfer. The embryo or embryos can then be thawed and transferred (FET) to achieve a live birth. However, it is necessary to first ensure that the transfer is carried out at a time when the endometrium is receptive, which is essential for embryo implantation and pregnancy. This period is defined as the "implantation window". Endometrial preparation can be performed by hormone replacement therapy (HRT) or moderate ovarian stimulation (SO). The implantation window can also be assessed by the monitoring of a natural cycle (NC). The choice of the key moment for the transfer is determined by ovulation and / or the rise of progesterone. To date, no study has demonstrated the superiority of one protocol over another in terms of birth rates. In the investigative center, treatment is usually carried out by daily subcutaneous injections of gonadotrophins followed by ovulation induction. In this context, the implementation of the FET in natural cycle may appear less burdensome for the patient and more physiological. The consideration is additional constraints, NC imposing more frequent monitoring (ultrasound and / or hormone assays) to detect the ovulation peak and less freedom in choosing the date of transfer. The average number of visits with SO is 2.6 per cycle. The aim of this study is to compare the stresses and safety of these two therapeutic proposals to determine the least restrictive for patients.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 4

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

  • France
      • Créteil, France, 94000
        • CHI Créteil

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

20 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Affiliation to the general social security regime and benefiting from 100% infertility;
  • Regular Cycles 26 to 35 days;
  • Support in IVF or ICSI ;
  • Existence of at least 2 frozen embryos to J2 or J3;
  • Treated for their first or second cycle of TEC.

Exclusion Criteria:

  • Donor sperm;
  • Irregular cycles and / or polycystic ovary syndrome;
  • Embryos frozen at J1 or J5 / J6 or double planned transfer or transfer of 3 embryos intended;
  • Patients who have had more than 3 transfers or more than 6 embryos replaced without pregnancy or puncture rank> 3;
  • uterine malformation existing;
  • Presence of a hydrosalpinx.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Natural cycle
Ovulation is not induced by drugs
Other: natural cycle
Ovulation is not induced by drugs
Other Names:
  • natural
Experimental: Moderate ovarian stimulation
Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin
Drug: moderate ovarian stimulation
Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin
Other Names:
  • ovarian stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of visits
Time Frame: From inclusion visit to embryo transfer : up to 90 days
number of visits (for clinical examination, ultrasound and hormonal dosage) required to monitor ovulation in both groups
From inclusion visit to embryo transfer : up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertiqol
Time Frame: From inclusion visit to embryo transfer : up to 90 days
the score of quality of life related to the couple's infertility, the Fertiqol questionnaire, a questionnaire validated by the European Society of Human Reproduction and Embryology (ESHRE) and taking into account the tolerance to treatment;
From inclusion visit to embryo transfer : up to 90 days
defrost cancellation rate
Time Frame: From inclusion visit to embryo transfer : up to 90 days
the defrost cancellation rate cycle started, whatever the cause: Early ovulation problem of organization, ... excluding "non-transfer" related to embryo lysis thawing
From inclusion visit to embryo transfer : up to 90 days
transfer on weekends and holidays
Time Frame: From inclusion visit to embryo transfer : up to 90 days
the transfer rate on weekends and holidays
From inclusion visit to embryo transfer : up to 90 days
HCG levels> 100 U / L
Time Frame: From inclusion visit to pregnancy test : up to 100 days
the incipient pregnancy rate per transfer defined by a HCG levels> 100 U / L
From inclusion visit to pregnancy test : up to 100 days
pregnancy
Time Frame: From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
the rate of pregnancy by ultrasound transfer defined by the presence of a cardiac activity
From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
Birth
Time Frame: From transfer to delivery : up to 9 months
The live birth rate per transfer defined by the birth of at least one living child
From transfer to delivery : up to 9 months
Gestationnal age at delivery
Time Frame: From transfer to delivery : up to 9 months
the term of delivery
From transfer to delivery : up to 9 months
Implantation
Time Frame: From transfer to delivery : up to 9 months
the implantation rate defined by the total number of live births to the total number of embryos replaced
From transfer to delivery : up to 9 months
Miscarriage
Time Frame: From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
the rate of early miscarriage (before 12 SA)
From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
Cost
Time Frame: From pregnancy test to ultrasound at 6 week of gestation : up to 100 days
the average estimated cost of drug treatment and monitoring (ultrasound and hormone assays).
From pregnancy test to ultrasound at 6 week of gestation : up to 100 days

Collaborators and Investigators

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

Sponsor

Dr Massin Nathalie

Investigators

  • Principal Investigator: Nathalie Massin, MD, CHIC

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)

May 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SONTEC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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 Fertility

Clinical Trials on natural cycle

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe