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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2009-009323-11 |
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| Name | Class |
|---|---|
| Oxford Fertility Unit | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Natural FER (frozen embryo replacement) | |
| 2 | Active Comparator | HRT-FER (Down regulated frozen embryo replacement) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nafarelin acetate, Oestradiol Valerate, Progesterone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The live birth rate in each group | 22 - 40 weeks following embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rates (CPR) | 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) | 4 weeks following embryo transfer (6/40 pregnancy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Child, MA MD MRCOG | Nuffield Department of Obstetrics and Gynaecology, University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuffield Department of Obstetrics and Gynaecology, University of Oxford | Oxford | Oxfordshire | OX3 9DU | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26255087 | Derived | Mounce G, McVeigh E, Turner K, Child TJ. Randomized, controlled pilot trial of natural versus hormone replacement therapy cycles in frozen embryo replacement in vitro fertilization. Fertil Steril. 2015 Oct;104(4):915-920.e1. doi: 10.1016/j.fertnstert.2015.07.1131. Epub 2015 Aug 5. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017274 | Nafarelin |
| D004958 | Estradiol |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| 3D endometrial volume and blood flow indices | various from day 1 to embryo transfer |
| Patient satisfaction with treatment | 4-10 weeks (at embryo transfer) |
| Oxford Fertility Unit |
| Oxford |
| Oxfordshire |
| OX4 2HW |
| United Kingdom |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |