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Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00843570
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : July 25, 2013
Oxford Fertility Unit
Information provided by (Responsible Party):
University of Oxford

Brief 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 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 or disease Intervention/treatment Phase
Infertility Drug: Nafarelin acetate, Oestradiol Valerate, Progesterone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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 Name: Synarel,Progynova,Cyclogest

Primary Outcome Measures :
  1. The live birth rate in each group [ Time Frame: 22 - 40 weeks following embryo transfer ]

Secondary Outcome Measures :
  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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00843570

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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
Sponsors and Collaborators
University of Oxford
Oxford Fertility Unit
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Principal Investigator: Tim Child, MA MD MRCOG Nuffield Department of Obstetrics and Gynaecology, University of Oxford
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Oxford Identifier: NCT00843570    
Other Study ID Numbers: FER01
EudraCT 2009-009323-11
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013
Keywords provided by University of Oxford:
Frozen Embryo Replacement
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Fertility Agents, Female
Fertility Agents