NCT02834117

Natural Cycle Versus Stimulated Cycle Before Frozen Embryo Transfer

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Dr Massin Nathalie · Academic / Other
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Fertility

Interventions

Type	Name	Description
OTHER	natural cycle	Ovulation is not induced by drugs
DRUG	moderate ovarian stimulation	Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-02-01
• Completion: 2018-03-01
• First posted: 2016-07-15
• Last updated: 2019-02-06

Locations

1 site across 1 country: France