Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment
Information source: University of Oxford
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Nafarelin acetate, Oestradiol Valerate, Progesterone (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Oxford Official(s) and/or principal investigator(s):
Tim Child, MA MD MRCOG, Principal Investigator, Affiliation: Nuffield Department of Obstetrics and Gynaecology, University of Oxford
Overall contact:
Ginny Mounce, MSc, Email: ginny.mounce@obs-gyn.ox.ac.uk
Summary
Frozen Embryo Replacement (FER)is a fertility treatment by which stored embryos from a fresh
IVF treatment cycle are thawed and transferred into the uterus. Frozen embryos can be
replaced either in the middle of a natural menstrual cycle (Natural FER) or in a cycle where
the woman takes drugs to suppress her own hormones, and then takes Hormone Replacement
Therapy (HRT) to prepare her uterus for the transfer of embryos(HRT − FER).
Both are widely used methods of fertility treatment. However, to date no well designed
studies have been reported in which the two methods have been compared. This study aims to
compare the two treatments in order to establish the best treatment protocol.
The study design is a single centre open randomized controlled trial funded by the Oxford
Fertility Unit.
100 women who are considering FER treatment at the Oxford Fertility Unit and are eligible
for the study will be recruited.
After giving their written consent they will be randomised to one of 2 groups: Natural FER
and HRT FER.
Patients in both groups will be asked to attend one initial visit, which is additional to
patients not taking part in the study.
Subsequent visits will depend on the treatment group but will not be additional for study
participants. All visits requiring ultrasound will involve recording 3âD measurements, which
increases the length of each visit by approximately 10 minutes. A patient satisfaction
questionnaire would be completed at the end of the cycle.
A urinary pregnancy test is performed at home 2 weeks following the embryo transfer visit.
If this is positive then further visits to the unit are arranged to confirm the clinical
pregnancy.
Inclusion in the study would not increase the length of time of either treatment cycle.
Follow up would extend to obtaining pregnancy outcome information.
Clinical Details
Official title: A Randomised Controlled Trial of Natural Versus Hormone Replacement Therapy Cycles in Frozen Embryo Replacement IVF: a Pilot Study
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: The live birth rate in each group
Secondary outcome: Clinical pregnancy rates (CPR)Implantation rate (defined as the number gestational sacs visible on ultrasound divided by the number of embryos
replaced and expressed in percentage) 3D endometrial volume and blood flow indicies Patient satisfaction with treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Women attending Oxford Fertility Unit planning a frozen embryo replacement cycle.
- Willing and able to give informed consent for participation in the study.
- Age at original fresh IVF cycle < 40 years old.
- At least 3 embryos frozen in storage
- First or second FER cycle
- Regular ovulatory menstrual cycles, confirmed by luteal progesterone levels >16nmol/L
and with cycle length < 35 days.
Exclusion Criteria:
- Women with irregular cycles (outlined above), including amenorrhoea or
oligomenorrhoea.
- Co-existing medical illness including renal, cardiac and liver disease
- Women for whom the study medication(s) are contraindicated or who have known allergic
reactions to study medication(s)
- Women who have already taken part in this trial (i. e. cannot have more than one
treatment cycle as a participant in this trial)
Locations and Contacts
Ginny Mounce, MSc, Email: ginny.mounce@obs-gyn.ox.ac.uk
Nuffield Department of Obstetrics and Gynaecology, University of Oxford, Oxford, Oxfordshire OX3 9DU, United Kingdom
Additional Information
Starting date: April 2009
Ending date: April 2011
Last updated: February 12, 2009
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