Ovarian ReserveNCT05562479
Effect of Sars-cov-2 on Donor Oocyte Quality and Quantity, a Multicenter Retrospective Study.
An observational study of Ovarian Reserve and SARS-CoV-2 Infection, run by Novafem at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Reserve, SARS-CoV-2 Infection, Blastocyst
- What is being tested?
- Sars Cov 2 infection and Sars Cov 2 vaccination
- Type of treatment
- Vaccines
- How many people
- 428 participants
- Where
- 1 siteColombia
- Study dates
- 12 Dec 2021to 18 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients were categorized into the vaccinated group if they had received two dosages of any SARS-CoV-2 vaccines with a break of at least three weeks between each dose. First and second vaccine dates were requested from 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 an adverse 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 before March 2020 to ensure they did not have an infection and were not vaccinated.
Who may be able to join
- Age: 18 - 32 Years
- Body Mass Index between 18 and 26
- AFC: Antral follicular count over 15 in total.
- AMH: Anti-Mullerian hormone over 2.5
- Signed consents.
- Covid vaccines and infection information (for case group).
Who cannot join
- Egg donors with incomplete information of days of stimulation, average dose of gonadotropins, the number of retrieved oocytes, mature oocytes, fertilised oocytes and top-quality embryos obtained.
- Familial genetic disorders.
- Menstrual cycle disorders.
- Polycystic ovary syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Ovarian Reserve, SARS-CoV-2 Infection, Blastocyst
- Being tested
- Sars Cov 2 infection, Sars Cov 2 vaccination
- Keywords
- COVID-19; SARS-CoV-2, embryos;, endometrium;, female reproductive system, in vitro fertilization;, menstrual cycle;, oocytes;, ovarian reserve, blastocyst
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sars Cov 2 infectionBiological
Donors recovered from Sars Cov 2 Infection
Sars Cov 2 vaccinationBiological
Egg Donors vaccinated
| Study group | Role | What they receive |
|---|---|---|
| Non exposed to Sars Cov 2 egg donors | Evaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation. Receives: Biological: Sars Cov 2 infection; Biological: Sars Cov 2 vaccination | |
| Exposed to Sars Cov 2 Infection | Evaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation, after being exposed to the infection. | |
| Exposed to Sars Cov 2 Vaccines | Evaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation, after being exposed to vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MII mature oocytes after retrieval
Measured: 2018 to 2022
Fertilization rate
Measured: 2018 to 2022
Blastocyst rate formation
Measured: 2018 to 2022
Secondary outcomes (1)
antral follicular count before retrieval
Measured: 2018 to 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start12 Dec 2021
- Primary completion15 Jul 2022
- Study completion18 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novafem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Pablo Saffon, Novafem
- Investigators
- Jose A Moreno, PhD, Study chair, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562479
- Sponsor's protocol ID
- Novafem
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sars-cov-2 on Donor Oocyte Quality and Quantity, a Multicenter Retrospective Study.
- ClinicalTrials.gov ID
- NCT05562479
- Acronym / sponsor ID
- Novafem
- Conditions
- Ovarian Reserve, SARS-CoV-2 Infection, Blastocyst
- Keywords
- COVID-19; SARS-CoV-2, embryos;, endometrium;, female reproductive system, in vitro fertilization;, menstrual cycle;, oocytes;, ovarian reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- NovafemUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 18 Sep 2022 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non exposed to Sars Cov 2 egg donors | – | Biological: Sars Cov 2 infection, Biological: Sars Cov 2 vaccinationEvaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation. |
| Exposed to Sars Cov 2 Infection | – | –Evaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation, after being exposed to the infection. |
| Exposed to Sars Cov 2 Vaccines | – | –Evaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation, after being exposed to vaccination. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients were categorized into the vaccinated group if they had received two dosages of any SARS-CoV-2 vaccines with a break of at least three weeks between each dose. First and second vaccine dates were requested from 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 an adverse 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 before March 2020 to ensure they did not have an infection and were not vaccinated.
Key inclusion criteria (6 listed)
- Age: 18 - 32 Years
- Body Mass Index between 18 and 26
- AFC: Antral follicular count over 15 in total.
- AMH: Anti-Mullerian hormone over 2.5
- Signed consents.
Key exclusion criteria (4 listed)
- Egg donors with incomplete information of days of stimulation, average dose of gonadotropins, the number of retrieved oocytes, mature oocytes, fertilised oocytes and top-quality embryos obtained.
- Familial genetic disorders.
- Menstrual cycle disorders.
- Polycystic ovary syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sars Cov 2 infectionDonors recovered from Sars Cov 2 Infection | Biological | Non exposed to Sars Cov 2 egg donors |
| Sars Cov 2 vaccinationEgg Donors vaccinated | Biological | Non exposed to Sars Cov 2 egg donors |
Primary outcome
MII mature oocytes after retrieval
Time frame: 2018 to 2022
Fertilization rate
Time frame: 2018 to 2022
Blastocyst rate formation
Time frame: 2018 to 2022
1 secondary outcome
antral follicular count before retrieval
Time frame: 2018 to 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Moreno, PhD study chair
Universitat Autonoma de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Reserve and SARS-CoV-2 Infection, run by Novafem at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MII mature oocytes after retrieval (time frame: 2018 to 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.