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Clinical Effectiveness of Frozen Thawed Embryo Transfer Compared to Fresh Embryo Transfer

2015-10-08 09:53:22 | BioPortfolio

Summary

The objective of the present randomized controlled study is to compare clinical effectiveness and safety of freezing all embryos followed by frozen-thawed embryo transfer (FET) compared to fresh embryo transfer, in women undergoing IVF treatment.

Description

A total of 800 infertile women undergoing IVF treatment will be randomized into one of the following two groups by computer-generated random numbers:

Fresh embryo transfer group: a single fresh embryo transfer FET group: a single FET following freezing of all embryos in the stimulated IVF cycle

All techniques of IVF including ovarian stimulation, harvesting of oocytes, insemination with specially prepared sperm and embryo culture in the laboratory will be according to local protocols. Once the embryos have been cultured up to day 2 or 3, women with 3 or more suitable quality embryos will be randomized to either fresh embryo transfer (control arm) or FET (Intervention arm).

Control arm Women allocated to the control arm will either undergo embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols.

Intervention arm For those allocated to the intervention arm fresh embryo transfer will not be undertaken. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer.

After at least 4 weeks women will attend the IVF clinic for the transfer of thawed frozen embryos, either in a natural cycle (in ovulatory women who have regular menstrual cycles) or in a hormonally supported cycle using physiological doses of estrogen and progestogens to mimic normal cyclical changes within the endometrium. The choice between replacing frozen-thawed embryos in a natural or hormonally mediated cycle will be a decision driven by the clinical circumstances.

Embryos or blastocysts will be thawed according to local protocols. The transfer is performed by the team clinician with a maximum of 2 embryos or blastocysts being replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given at the discretion of the physician.

Follow up strategy:

A pregnancy test will be carried out 2 weeks after embryo transfer in both arms. All women who have a positive pregnancy test 2 weeks after embryo transfer will undergo a transvaginal ultrasound scan to identify the presence and number of a gestation sac with a fetal heart signifying an ongoing pregnancy. Pelvic scan will be repeated at 8 weeks, 12 weeks, 24 weeks and 36 gestation for fetal growth.

Data on all pregnancy outcomes including early pregnancy losses such as miscarriage or ectopic pregnancy will be collected.

In order to achieve consistency with respect to the collection of outcome, standardised case report forms (CRF) will be completed for each woman at each centre. These CRFs will include details on treatment received, pregnancy outcomes, complications in pregnancy, mode of delivery and birth outcomes.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Subfertility

Intervention

Fresh embryo transfer, Frozen embryo transfer

Location

Department of Obstetrics and Gynaecology
Hong Kong
Hong Kong
China

Status

Not yet recruiting

Source

The University of Hong Kong

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-10-08T09:53:22-0400

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Medical and Biotech [MESH] Definitions

The techniques used to select and/or place only one embryo from FERTILIZATION IN VITRO into the uterine cavity to establish a singleton pregnancy.

The transfer of mammalian embryos from an in vivo or in vitro environment to a suitable host to improve pregnancy or gestational outcome in human or animal. In human fertility treatment programs, preimplantation embryos ranging from the 4-cell stage to the blastocyst stage are transferred to the uterine cavity between 3-5 days after FERTILIZATION IN VITRO.

The transfer of energy of a given form among different scales of motion. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed). It includes the transfer of kinetic energy and the transfer of chemical energy. The transfer of chemical energy from one molecule to another depends on proximity of molecules so it is often used as in techniques to measure distance such as the use of FORSTER RESONANCE ENERGY TRANSFER.

A medical-surgical specialty concerned with the morphology, physiology, biochemistry, and pathology of reproduction in man and other animals, and on the biological, medical, and veterinary problems of fertility and lactation. It includes ovulation induction, diagnosis of infertility and recurrent pregnancy loss, and assisted reproductive technologies such as embryo transfer, in vitro fertilization, and intrafallopian transfer of zygotes. (From Infertility and Reproductive Medicine Clinics of North America, Foreword 1990; Journal of Reproduction and Fertility, Notice to Contributors, Jan 1979)

The developmental entity of a fertilized egg (ZYGOTE) in animal species other than MAMMALS. For chickens, use CHICK EMBRYO.

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