Skip to main content
OpenTrials
Completed

NCT Number: NCT03998553

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ivi Valencia

Valencia, 46015, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IN VITRO MATURATION AND OOCYTE ACTIVATION

Procedure

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.

Primary outcomes

  1. rate of obtaining potentially competent oocytes

    Time frame: 6 months

    Number of potentially competent oocytes (after in vitro maturation and oocyte activation).

Secondary outcomes

  1. Oocyte retrieval rate

    Time frame: 6 months

    Number of Oocyte retrieved per punctured follicle.

  2. Artificial oocyte activation rate.

    Time frame: 6 months

    Number of activated oocyte obtained.

  3. In vitro nuclear maturation rate.

    Time frame: 6 months

    Number of oocyted with matured nucleous.

  4. Fertilization rate

    Time frame: 6 months

    Number of Fertilized oocytes obtained in a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.

  5. Mature oocytes rate

    Time frame: 6 months

    Number of Mature oocytes obtained in of a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Acronym: IVM

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2019
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.