Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: Nafarelin acetate, Oestradiol Valerate, Progesterone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised Controlled Trial of Natural Versus Hormone Replacement Therapy Cycles in Frozen Embryo Replacement IVF: a Pilot Study |
- The live birth rate in each group [ Time Frame: 22 - 40 weeks following embryo transfer ] [ Designated as safety issue: No ]
- Clinical pregnancy rates (CPR) [ Time Frame: 4 weeks after embryo transfer (at 6/40 pregnancy) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 3D endometrial volume and blood flow indices [ Time Frame: various from day 1 to embryo transfer ] [ Designated as safety issue: No ]
- Patient satisfaction with treatment [ Time Frame: 4-10 weeks (at embryo transfer) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United Kingdom | |
| 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 |
More Information
No publications provided
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT00843570 History of Changes |
| Other Study ID Numbers: | FER01, EudraCT 2009−009323−11 |
| Study First Received: | February 12, 2009 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
Keywords provided by University of Oxford:
|
IVF Frozen Embryo Replacement |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Estradiol Polyestradiol phosphate Progesterone Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Nafarelin Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Progestins Fertility Agents, Female Fertility Agents |
ClinicalTrials.gov processed this record on May 23, 2013