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OpenTrials
Completed

NCT Number: NCT02834117

Natural Cycle Versus 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.

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Key information

Conditions

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CHI Creteil

Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

natural cycle

Other

Ovulation is not induced by drugs

Other names: natural

moderate ovarian stimulation

Drug

Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin

Other names: ovarian stimulation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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;

  2. 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

  3. transfer on weekends and holidays

    Time frame: From inclusion visit to embryo transfer : up to 90 days

    the transfer rate on weekends and holidays

  4. 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

  5. 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

  6. 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

  7. Gestationnal age at delivery

    Time frame: From transfer to delivery : up to 9 months

    the term of delivery

  8. 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

  9. 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)

  10. 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).

Sponsors and collaborators

Lead sponsor

Dr Massin Nathalie

Other

Registry information

Official study title

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

Acronym: SONTEC

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 15, 2016
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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