Female Infertility Clinical Trial
— PEOfficial title:
The Neverending Debate on Progesterone Elevation: Possible Solutions
NCT number | NCT04253470 |
Other study ID # | 2020xxxx |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2012 |
Est. completion date | October 1, 2019 |
Verified date | January 2020 |
Source | Istituto Clinico Humanitas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The association between serum progesterone (P) levels, measured on the day of ovulation
trigger, and the outcome of in vitro fertilization cycles, has been one of the major
controversies in the field of ovarian stimulation endocrinology.
This is a single-center retrospective cohort study. Study duration period is from January
2012 to December 2016.
All fresh embryo transfer (ET) both at cleavage stage and blastocyst stage, performed in
Humanitas Fertility Center during the study period, were included.
Status | Completed |
Enrollment | 8000 |
Est. completion date | October 1, 2019 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5) - Thawed embryo transfer deriving from supernumerary embryos cycles, by P increase, by OHSS, by other reasons (i.e inadequate endometrium, medical complications, etc) Exclusion Criteria: - thawed embryo transfers deriving from PGTA. |
Country | Name | City | State |
---|---|---|---|
Italy | Paolo Emanuele Levi Setti | Rozzano | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of PE on CPR and LBR | To evaluate the impact of premature high serum P levels on the outcome of fresh embryo transfer cycles in terms of Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR). | January 2012-December 2016 | |
Secondary | Blastocyst embryo transfers' outcomes in PE | Furthermore, the present study retrospectively investigates whether the transfer of blastocysts on day 5 post-fertilization (D5-ET) may improve the CPR and the LBR in patients with P rise. | January 2012-December 2016 |
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