Sub-optimal Culture Conditions Clinical Trial
Official title:
The Blastocyst Development and Clinical Outcome in Single Step Medium With or Without Renewal on Day 3 in a Time-lapse Incubator
| NCT number | NCT02778217 |
| Other study ID # | 006734 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | May 17, 2016 |
| Last updated | June 10, 2016 |
| Start date | May 2016 |
Culture media used to support development of zygotes to the blastocyst stage is based on two
basic philosophies: a single step medium "let-the-embryo-choose" or a sequential medium
"back-to-nature".
For single step media, there are two types of protocol can be used for the culture of human
preimplantation embryos:
1. Interrupted single medium culture, in which the medium is renewed on the Day 3 of
embryo culture
2. Uninterrupted single embryo culture, in which the same single medium is used throughout
the 5-6 days of culture with no replenishment or replacement on Day 3.
Investigators aim to compare the blastocyst development and clinical outcome between the two
types of protocols of a single medium (with or without renewal on Day 3)
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 19 Years to 39 Years |
| Eligibility |
Inclusion Criteria: - female partners were under the age of 39 years - Intracytoplasmic sperm injection (ICSI) was performed using fresh ejaculates Exclusion Criteria: - Day 3 embryo transfer cycles |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Sunrise fertility center | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Dar Almaraa Fartility and Gynacology Center |
Egypt,
Costa-Borges N, Bellés M, Meseguer M, Galliano D, Ballesteros A, Calderón G. Blastocyst development in single medium with or without renewal on day 3: a prospective cohort study on sibling donor oocytes in a time-lapse incubator. Fertil Steril. 2016 Mar;1 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical pregnancy rate | diagnosed by the presence of a heartbeat in the gestational sac visualized by ultrasound | 4 weeks post embryo transfer | Yes |
| Secondary | Implantation rate | the number of intrauterine gestational sacs over the total number of embryos transferred | 4-6 weeks post embryo transfer | Yes |
| Secondary | Blastocyst formation rate | 5-6 days post intracytoplasmic sperm injection | Yes |