Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05562479 |
| Other study ID # |
Novafem |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 12, 2021 |
| Est. completion date |
September 18, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Novafem |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Purpose: To determine the impact of SARS-CoV-2 infection and immunization on ovarian response
to controlled ovarian stimulation (COS) and embryo development after in vitro fertilization
(IVF) Methods: A retrospective multicentric cohort study of 427 oocyte donors was conducted
between January 1st, 2018 and September 18th, 2022. Patients who recovered from SARS-CoV-2
infection, vaccinated or non-exposed were included. Demographic, cycle characteristics, and
laboratory outcomes were compared.
Description:
This was a multicenter retrospective cohort study performed at the Centro de Fertilidad y
Genetica Novafem, Bogota, Colombia, and Clinica de la Mujer - Medicina Reproductiva, Viña del
Mar, Chile. The Ethics Committee approved the study protocol of both centers. Informed
contents were obtained from patients for data collection with scientific use.
All donors who underwent COS for oocyte donation between January 1st, 2018 and July 31th,
2022 were screened for eligibility and followed up to September 18th, 2022.
Oocyte donation cycles were utilized because this model is an excellent choice for
controlling known female characteristics. Previous research concluded that a major predictor
of ART outcomes is maternal age.
Eligibility criteria were donors aged older than 18 years or younger than 35 years. After
providing informed consent, the patients were questioned about their confirmed past
SARS-Cov-2 infection/vaccination status. Patients were categorized into the vaccinated group
if they had received two dosages of any SARS-CoV-2 vaccines (BNT162b2 mRNA Pfizer-Biontech,
mRNA-1273 Moderna or inactivated SARS-CoV-2 vaccine Sinovac) with a break of at least three
weeks between each dose. First and second vaccine dates were requested of vaccinated
patients. Vaccine administration details, such as vaccine type, dose, date, manufacturer, and
lot number, were collected from immunization records.
For recovering patients, the date of a negative nasopharyngeal COVID polymerase chain
reaction (PCR) test was registered. None of the recovering patients were vaccinated with any
SARS-CoV-2 vaccine. Both clinics strictly required a negative PCR test for SARS-CoV-2 RNA
detection 5 days before oocyte retrieval, except for those patients who were less than 3
months following recovery from SARS-Cov-2 infection. Patients in the control group were
selected from medical records prior to March 2020 to ensure they did not have the infection
and were not vaccinated.
Data including the patient age, body mass index (BMI), antral follicle count (AFC), anti
mullerian hormone (AMH), days of stimulation, average dose of gonadotropins, the number of
retrieved oocytes, mature oocytes, fertilized oocytes and top quality embryos obtained were
recorded. Other parameters were calculated such as the ratio between the number of retrieved
oocytes and the number of mature follicles in order to assess the adequacy of response of the
follicle to the LH/hCG trigger; the fertilization rate (FR), which was defined as the
proportion of inseminated oocytes with 2PN at the time of the fertilization check on Day 1
and finally the blastocyst development rate, defined as the proportion of 2PN zygotes which
are at the blastocyst stage at Day 5.
All analyses were performed using SPSS 23.0 (SPSS Inc., Chicago, IL, USA). Normally,
distributed data were compared across study groups by univariate ANOVA. All P-values were
tested as two-tailed and considered significant at <0.05.
