Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment

NCT00843570 | Completed Phase 4 DMC

• 2 other identifiers: FER01EudraCT 2009-009323-11
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility

Keywords

IVF; Frozen Embryo Replacement

Outcome Measures

Primary Outcomes (1)

• The live birth rate in each group

  22 - 40 weeks following embryo transfer

Secondary Outcomes (4)

• Clinical pregnancy rates (CPR)

  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)

  4 weeks following embryo transfer (6/40 pregnancy)

• 3D endometrial volume and blood flow indices

  various from day 1 to embryo transfer

• Patient satisfaction with treatment

  4-10 weeks (at embryo transfer)

Study Arms (2)

1

NO INTERVENTION

Natural FER (frozen embryo replacement)

2

ACTIVE COMPARATOR

HRT-FER (Down regulated frozen embryo replacement)

Drug: Nafarelin acetate, Oestradiol Valerate, Progesterone

Interventions

Nafarelin acetate, Oestradiol Valerate, Progesterone DRUG

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

Also known as: Synarel,Progynova,Cyclogest

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead
• Oxford Fertility Unit: collaborator

Study Sites (2)

Nuffield Department of Obstetrics and Gynaecology, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Oxford Fertility Unit

Oxford, Oxfordshire, OX4 2HW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26255087 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Nafarelin; Estradiol; Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Study Officials

• Tim Child, MA MD MRCOG

  Nuffield Department of Obstetrics and Gynaecology, University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

GB (2)