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A randomised controlled trial of natural versus hormone replacement therapy cycles in frozen embryo replacement IVF: a pilot study - Natural versus HRT cycles in frozen embryo replacement treatment

Phase 1
Conditions
Infertility - specifically in those women intending to undertake a frozen embryo replacement treatment who have at least 3 embryos fozen in storage and who are planning a first or second frozen embryo replacment cycle treatment.
MedDRA version: 14.1 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders
Registration Number
EUCTR2009-009323-11-GB
Lead Sponsor
niversity of Oxford
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

. Women attending OFU planning a frozen embryo replacement cycle. . Women willing and able to give informed consent for participation in the study. . Age at original fresh IVF cycle < 40 years old. . At least 2 embryos frozen in storage or 1 vitrified blastocyst in storage. . First, second or third FER cycle. . Regular ovulatory menstrual cycle, confirmed by luteal progesterone levels >16 nmol/L and with cycle length < 35 days.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

. Women with irregular cycles, including amenorrhea or oligomenorrhea . 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) .Women who have previously been involved in trials involving medicinal products in the last 6 months

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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