Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00843570|
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : July 25, 2013
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 3−D 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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Nafarelin acetate, Oestradiol Valerate, Progesterone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial of Natural Versus Hormone Replacement Therapy Cycles in Frozen Embryo Replacement IVF: a Pilot Study|
|Study Start Date :||November 2009|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
No Intervention: 1
Natural FER (frozen embryo replacement)
Active Comparator: 2
HRT-FER (Down regulated frozen embryo replacement)
Drug: Nafarelin acetate, Oestradiol Valerate, Progesterone
Nafarelin acetate, Nasal spray, 400 mcg b.d., 4 weeks Oestradiol Valerate, tablet, 2mg o.d day 1-5, 2mg b.d. day 6-9, 2mg t.d.s day 10-13 (step-up protocol), 2mg q.d.s (if pregnancy confirmed, 4-10 weeks Progesterone, pessary, 200mg b.d. and t.d.s. (if pregnancy confirmed), 2-10 weeks
Other Name: Synarel,Progynova,Cyclogest
- The live birth rate in each group [ Time Frame: 22 - 40 weeks following embryo transfer ]
- Clinical pregnancy rates (CPR) [ Time Frame: 4 weeks after embryo transfer (at 6/40 pregnancy) ]
- Implantation rate (defined as the number gestational sacs visible on ultrasound divided by the number of embryos replaced and expressed in percentage) [ Time Frame: 4 weeks following embryo transfer (6/40 pregnancy) ]
- 3D endometrial volume and blood flow indices [ Time Frame: various from day 1 to embryo transfer ]
- Patient satisfaction with treatment [ Time Frame: 4-10 weeks (at embryo transfer) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843570
|Nuffield Department of Obstetrics and Gynaecology, University of Oxford|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Oxford Fertility Unit|
|Oxford, Oxfordshire, United Kingdom, OX4 2HW|
|Principal Investigator:||Tim Child, MA MD MRCOG||Nuffield Department of Obstetrics and Gynaecology, University of Oxford|