Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment

Sponsor

University of Oxford (Other)

Overall Status

Completed

CT.gov ID

NCT00843570

Collaborator

Oxford Fertility Unit (Other)

159

Enrollment

Locations

Arms

Duration (Months)

79.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Nov 1, 2009

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The live birth rate in each group [22 - 40 weeks following embryo transfer]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nuffield Department of Obstetrics and Gynaecology, University of Oxford	Oxford	Oxfordshire	United Kingdom	OX3 9DU
2	Oxford Fertility Unit	Oxford	Oxfordshire	United Kingdom	OX4 2HW