Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment

NCTNCT00843570 (opens ClinicalTrials.gov in a new tab)Other idFER01Other idEudraCT 2009-009323-11
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
159 participants (actual)
Sponsor
University of Oxford · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United Kingdom

Start
Nov 2009
Primary completion
May 2013
Completion
May 2013
First posted
13 Feb 2009 (estimated)
Last update posted
25 Jul 2013 (estimated)
Conditions
Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011201220132014
  1. Ph 4

    Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment

    NCT00843570

    Nov 2009 to May 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Nafarelin acetate, Oestradiol Valerate, ProgesteroneDrug

Arms2

  • No intervention

    1

    Natural FER (frozen embryo replacement)

  • Active comparator

    2

    HRT-FER (Down regulated frozen embryo replacement)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The live birth rate in each group

    Time frame · 22 - 40 weeks following embryo transfer

Secondary outcomes(4)

  1. Clinical pregnancy rates (CPR)

    Time frame · 4 weeks after embryo transfer (at 6/40 pregnancy)

  2. 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)

  3. 3D endometrial volume and blood flow indices

    Time frame · various from day 1 to embryo transfer

  4. Patient satisfaction with treatment

    Time frame · 4-10 weeks (at embryo transfer)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedMounce 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. PMID 26255087

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

PepBank is a research reference. Talk to a doctor before you use any peptide.