InfertilityPhase 4NCT00843570
Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment
A Phase 4 study testing Nafarelin acetate, Oestradiol Valerate, Progesterone in people with Infertility, run by University of Oxford at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Nafarelin acetate, Oestradiol Valerate, Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2009to May 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nuffield Department of Obstetrics and Gynaecology, University of Oxford
Oxford, Oxfordshire, OX3 9DU
Oxford Fertility Unit
Oxford, Oxfordshire, OX4 2HW
About this study
Official title: A Randomised Controlled Trial of Natural Versus Hormone Replacement Therapy Cycles in Frozen Embryo Replacement IVF: a Pilot Study
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.
Read more
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.
- Conditions
- Infertility
- Being tested
- Nafarelin acetate, Oestradiol Valerate, Progesterone
- Keywords
- IVF, Frozen Embryo Replacement
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nafarelin acetate, Oestradiol Valerate, ProgesteroneDrug
Also called Synarel,Progynova,Cyclogest
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Natural FER (frozen embryo replacement) |
| 2 | Active comparator | HRT-FER (Down regulated frozen embryo replacement) Receives: Drug: Nafarelin acetate, Oestradiol Valerate, Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The live birth rate in each group
Measured: 22 - 40 weeks following embryo transfer
Secondary outcomes (4)
Clinical pregnancy rates (CPR)
Measured: 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)
Measured: 4 weeks following embryo transfer (6/40 pregnancy)
3D endometrial volume and blood flow indices
Measured: various from day 1 to embryo transfer
Patient satisfaction with treatment
Measured: 4-10 weeks (at embryo transfer)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Fertility Unit
- Responsible party
- Sponsor
- Investigators
- Tim Child, MA MD MRCOG, Principal investigator, Nuffield Department of Obstetrics and Gynaecology, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843570
- Sponsor's protocol ID
- FER01
- Other IDs
- EudraCT 2009-009323-11
- Status last verified
- Jul 2013
- First submitted
- 12 Feb 2009
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26255087
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Natural Versus Hormone Replacement Therapy Cycles in Frozen Embryo Replacement IVF: a Pilot Study
- ClinicalTrials.gov ID
- NCT00843570
- Acronym / sponsor ID
- FER01
- Conditions
- Infertility
- Keywords
- IVF, Frozen Embryo Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford Fertility Unit
- Study start
- Nov 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Natural FER (frozen embryo replacement) |
| 2 | Active comparator | Drug: Nafarelin acetate, Oestradiol Valerate, ProgesteroneHRT-FER (Down regulated frozen embryo replacement) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nafarelin acetate, Oestradiol Valerate, ProgesteroneAlso: Synarel,Progynova,CyclogestNafarelin 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 | Drug | 2 |
Primary outcome
The live birth rate in each group
Time frame: 22 - 40 weeks following embryo transfer
4 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- Derived from this study: PubMed 26255087Mounce 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Child, MA MD MRCOG principal investigator
Nuffield Department of Obstetrics and Gynaecology, University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nafarelin acetate, Oestradiol Valerate, Progesterone in people with Infertility, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The live birth rate in each group (time frame: 22 - 40 weeks following embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00843570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.