Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women

Female Infertility Clinical Trial

— IVM  

Official title:

Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998553
• Other study ID #: 1901-VLC-006-EB
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: December 17, 2019

Study information

• Verified date: January 2020
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In vitro maturation (IVM) is a technique for obtaining potentially fertilizable oocytes from immature oocytes. An oocyte must be mature both nuclearly and cytoplasmically in order to be competent in the reproductive process. Nuclear maturation involves an oocyte in metaphase II stage and is easily evaluated for its morphology. However, cytoplasmic maturation can only be evaluated by in vitro fertilization of that oocyte A mature nuclear and cytoplasmic oocyte is one capable of producing a viable embryo. This study aims to fine-tune the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.

The aim of this study is to evaluate the response to the strategy stimulation with highly purified human menopausal gonadotropin (hMG-HP) administered for three days, in association with a standard methodology of in vitro oocyte maturation (IVM), to be performed on oocyte donors.

The correct functioning of this IVM technique would mean a reduction in the costs of ovarian stimulation treatments, as lower doses and shorter stimulation times are required, which implies lower risks for women derived from the medication and less stress for them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Woman aged 18-35 years who have belonged to the egg donation program.

• Donors who agree to participate in the pre-trial report and sign informed consent.

• Good previous documented response to ovarian stimulation (at least 10 oocytes total and/or 8 MII).

• Donors with at least one previous cycle of donation, in which all the oocytes obtained were fertilized in fresh

• Patients who come to their last cycle of donation allowed by law

• No personal or family medical disorders history.

• Body mass index between 18-28 kg/m2

• Normal uterus and ovaries, without organic pathology

• Non-polycystic-looking ovaries

• Antral follicle Count (AFC) > 12 from both ovaries on day 2-3 of the menstrual cycle.

• Normal Karyotype

• Negative values of infectious diseases (hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis)

• Analytical with CBC, hemostasis and biochemistry with parameters within normality

Exclusion Criteria:

• Any systemic or metabolic disorder that counterindicates the use of gonadotrophins.

• Any medical condition involving non-inclusion in the oocyte donation program

• Who are taking hormonal contraceptives in the last 3 months

• Severe male Factor (Semen < 3 million)

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Procedure:
• IN VITRO MATURATION AND OOCYTE ACTIVATION
This study aims to fine-tune the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.

Locations

Country	Name	City	State
Spain	Ivi Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of obtaining potentially competent oocytes	Number of potentially competent oocytes (after in vitro maturation and oocyte activation).	6 months
Secondary	Oocyte retrieval rate	Number of Oocyte retrieved per punctured follicle.	6 months
Secondary	Artificial oocyte activation rate.	Number of activated oocyte obtained.	6 months
Secondary	In vitro nuclear maturation rate.	Number of oocyted with matured nucleous.	6 months
Secondary	Fertilization rate	Number of Fertilized oocytes obtained in a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.	6 months
Secondary	Mature oocytes rate	Number of Mature oocytes obtained in of a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.	6 months