Comparing different ways of preparing patients for frozen-thawed embryo transfer

Conditions: Subfertility in need of IVF and IVF-ICSI treatment.
MedDRA version: 14.1Level: LLTClassification code 10042391Term: SubfertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2008-002689-68-NL

Lead Sponsor: Isala Klinieken, location Sophia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 1150

Inclusion Criteria

- Patients between 18 and 40 years, receiving frozen thawed embryo transfer arised from treatment cycle 1,2 or 3
- Patients willing to participate during 1 treatment cycle and willing to sign informed consent
- Ovulatory cycle betwee 26 and 35 days
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with a contraindication for one of the used medicines: liverfailure, history of trombisis, estrogen sensitive tumors, history of breastcancer. Profyri
- Patients with a known allergy to one of the used medicines
- Anovulation
- Uterine abonomalities
- Cryo-thawed embryo's arrised from oocyte donor treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare live birth rates among patients receiving cryo thawed embryo transfer after endometrial preparation with estrogen/progesterone substitution and patients receiving cryo thawed embryo transfer in a natural cycle.;Secondary Objective: Clinical pregnancy rate, ongoing pregancy rate, endometrial thickness, cancellation rates. Cost-efficiancy calculation. Perceived stress and burden.;Primary end point(s): live birth rate per started cryo cyclus;Timepoint(s) of evaluation of this end point: at the end of inclusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): endometrium thickness, clinical and ongoing pregnancy rates, cancellation rates. Serious adverse events;Timepoint(s) of evaluation of this end point: at the end of inclusion