Effect of Sars-cov-2 on Donor Oocyte Quality and Quantity, a Multicenter Retrospective Study.

NCT05562479 | Completed

• 1 other identifier: Novafem
• Study Type: observational
• Target: 428
• Locations: 1 country
• Sites: 1

Brief 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.

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; blastocyst

Outcome Measures

Primary Outcomes (3)

• MII mature oocytes after retrieval

  2018 to 2022

• Fertilization rate

  2018 to 2022

• Blastocyst rate formation

  2018 to 2022

Secondary Outcomes (1)

• antral follicular count before retrieval

  2018 to 2022

Study Arms (3)

Non exposed to Sars Cov 2 egg donors

Evaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation.

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.

Interventions

Sars Cov 2 infection BIOLOGICAL

Donors recovered from Sars Cov 2 Infection

Non exposed to Sars Cov 2 egg donors

Sars Cov 2 vaccination BIOLOGICAL

Egg Donors vaccinated

Non exposed to Sars Cov 2 egg donors

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novafem: lead

Study Sites (1)

Novafem

Bogotá, Colombia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jose A Moreno, PhD

  Universitat Autonoma de Barcelona

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: September 30, 2022
• Study Start: December 12, 2021
• Primary Completion: July 15, 2022
• Study Completion: September 18, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

CO (1)