Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment

This study has been completed.
Sponsor:
Collaborator:
Oxford Fertility Unit
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00843570
First received: February 12, 2009
Last updated: July 24, 2013
Last verified: July 2013

February 12, 2009
July 24, 2013
November 2009
May 2013   (final data collection date for primary outcome measure)
The live birth rate in each group [ Time Frame: 22 - 40 weeks following embryo transfer ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00843570 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 indicies [ 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 ]
Not Provided
Not Provided
 
Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
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
  • No Intervention: 1
    Natural FER (frozen embryo replacement)
  • Active Comparator: 2
    HRT-FER (Down regulated frozen embryo replacement)
    Intervention: Drug: Nafarelin acetate, Oestradiol Valerate, Progesterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
May 2013
May 2013   (final data collection date for primary outcome measure)

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)
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00843570
FER01, EudraCT 2009−009323−11
Yes
University of Oxford
University of Oxford
Oxford Fertility Unit
Principal Investigator: Tim Child, MA MD MRCOG Nuffield Department of Obstetrics and Gynaecology, University of Oxford
University of Oxford
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP