Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment

July 24, 2013 updated by: University of Oxford

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Nuffield Department of Obstetrics and Gynaecology, University of Oxford
      • Oxford, Oxfordshire, United Kingdom, OX4 2HW
        • Oxford Fertility Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Synarel,Progynova,Cyclogest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The live birth rate in each group
Time Frame: 22 - 40 weeks following embryo transfer
22 - 40 weeks following embryo transfer

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rates (CPR)
Time Frame: 4 weeks after embryo transfer (at 6/40 pregnancy)
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)
4 weeks following embryo transfer (6/40 pregnancy)
3D endometrial volume and blood flow indices
Time Frame: various from day 1 to embryo transfer
various from day 1 to embryo transfer
Patient satisfaction with treatment
Time Frame: 4-10 weeks (at embryo transfer)
4-10 weeks (at embryo transfer)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Oxford Fertility Unit

Investigators

  • Principal Investigator: Tim Child, MA MD MRCOG, Nuffield Department of Obstetrics and Gynaecology, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

July 25, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER01
  • EudraCT 2009-009323-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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