Suspended

IVMIn Vitro Maturation (IVM) of Human Oocytes

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What is being tested

In Vitro maturation

Biological
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Adnexal Diseases

From 25 to 42 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2015
See protocol details

Summary

Principal SponsorNorthwell Health
Last updated: November 16, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2015

Actual date on which the first participant was enrolled.

Natural IVF/IVM may be an attractive treatment alternative to conventional controlled ovarian hyperstimulation (COH)/IVF treatment for infertile women in particular for a select group. Natural IVF/IVM offers several advantages over conventional COH protocols for IVF including: Elimination of the need for gonadotropin ovarian stimulation Elimination of risk of developing OHSS Simplification of treatment, eliminating the need for frequent blood tests and ultrasound monitoring Reduced cost of treatment Avoiding potential side effects of gonadotropins, including weight gain, bloating, breast tenderness, nausea, mood swings Eliminates concerns about the potential risk of malignancy that may be associated with multiple cycles of ovarian stimulation in a predisposed population. This pilot study will be conducted to assess the clinical efficacy of natural IVF/IVM

NCT01843569
Principal SponsorNorthwell Health
Last updated: November 16, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 25 to 42 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCystsEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGonadal DisordersNeoplasmsOvarian CystsOvarian DiseasesFemale Urogenital DiseasesPolycystic Ovary Syndrome

Criteria

5 inclusion criteria required to participate
Each subject must be <= 42 years of age at the time of signing informed consent
Each subject must be female
Each subject must be willing and able to provide written informed consent for the trial
Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou [PAP] I or II) obtained within 12 months prior to signing informed consent must be available
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5 exclusion criteria prevent from participating
Subject tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid)
Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone
Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction
Subject with malformation or absence of uterus
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All patients registered in this study will undergo natural cycle IVF with In Vitro maturation (IVM) performed on all immature retrieved oocytes.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The Center for Human Reproduction

Manhasset, United StatesOpen The Center for Human Reproduction in Google Maps
SuspendedOne Study Center