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NCT01943812 Clinical Trial

Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation

Pregnancy Loss Clinical Trial

Official title:
Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01943812
Other study ID # Skive-2013-BA
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2013
Est. completion date April 2020

Study information
Verified date June 2020
Source Regionshospitalet Viborg, Skive
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare two FET protocols by modifying the substituted FET cycle in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early pregnancy loss.

Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early pregnancy loss.

Recruitment information / eligibility
Status Completed
Enrollment 287
Est. completion date April 2020
Est. primary completion date April 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Endometrial thickness = 7 mm after stimulation

- 18-45 years

- IVF/ICSI fertilisation

- BMI > 18,5 <30 kg/m2

- cycle length 25-34 days

Exclusion Criteria:

- endometrial thickness < 7 mm or no triple layer endometrium and/or functional follicles

- Uterine abnormality

- Chronic medical disease

- oocyte donation cycles

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Estradiol and progeterone
Estradiol and progesterone

Locations
Country Name City State
Denmark IVF syd Fredericia
Denmark Fertility Clinic Regional Hospital Skive Skive

Sponsors (1)
Lead Sponsor Collaborator
Peter Humaidan

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Luteal progesterone levels 7th week of gestation
Primary Pregnancy loss rate Primary outcome is avaible after 12th week of gestational.
Secondary Pregnancy rate 14 days after embryo transfer.
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