Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

all patients in this pilot study will undergo IVM. IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.

Peter G. McGovern, MD

This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment.

In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).

In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)

In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study

University Reproductive Associates

Medical Director

Immune System Diseases

Hypersensitivity

Ovarian Hyperstimulation Syndrome

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

In Vitro maturation

Avner Hershlag, MD

We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected population of infertility patients who cannot tolerate exogenous gonadotropins or are at risk of ovarian hyperstimulation syndrome.

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:

1. Elimination of the need for gonadotropin ovarian stimulation
2. Elimination of risk of developing OHSS
3. Simplification of treatment, eliminating the need for frequent blood tests and ultrasound monitoring
4. Reduced cost of treatment
5. Avoiding potential side effects of gonadotropins, including weight gain, bloating, breast tenderness, nausea, mood swings
6. 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

In Vitro Maturation (IVM) of Human Oocytes

Northwell Health

Immature oocytes were vitrified using closed system vitrification. After warming, they were cultured during 36 hours in IVM medium and fixed for cellular analysis

Immature oocytes were cultured in vitro in IVM medium during 36 hours. After IVM, they were vitrified. After warming, they were fixed for cellular analysis.

Immature oocytes were cultured in vitro in IVM medium during 36 hours and subsequently, fixed for cellular analysis.

Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system (Vitrolife). Kinetic of maturation were analyzed by Primovision (Vitrolife) and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.

Oocyte vitrification

Patrick LACARIN

Florence BRUGNON

Aïcha METCHAT

Human oocyte cryopreservation is routinely used for fertility preservation of women who will be exposed to gonadotoxic effect of cancer treatment. After ovarian stimulation, matured oocytes are vitrified. However, this strategy cannot always be used, particularly for hormone-sensitive cancer or when ovarian stimulation is not possible. An approach including immature oocytes and in vitro maturation (IVM) could be considered in these cases. While some qualitative analysis of oocytes vitrified before or after IVM suggest that vitrification should be performed after IVM, little is known about vitrification effects on actin and tubulin cytoskeleton and kinetic of maturation of human ovocytes.

To answer to this question, Investigator performed quantitive analyses comparing matured oocytes from three different groups: vitrified before IVM or after IVM and non-vitrified oocytes. Non-vitrified matured oocytes were used as a control. Different parameters have been analysed during maturation and in matured oocytes.

Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system ("Vitrolife"). Kinetic of maturation were analyzed by Primovision ("Vitrolife") and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.

Comparison of Vitrification Effect Before or After In Vitro Maturation

Characterization of a Method of Fertility Preservation for Patients Diagnosed for a Cancer

After oocytes retrieval, immature oocytes will be vitrified (Rapid Vit Ovocyte®, Vitrolife) in a closed system (Rapid-I®, Vitrolife) and thawed for in vitro maturation few days after. The meiotic process will be analyzed by time lapse technology (Primovision®, Vitrolife). This will permit to score the time of maturation from resumption to polar body extrusion of ovocytes.

Metaphase-II stage oocytes from both protocols will be used for Immuno-Fluorescence experiments to stain actin, tubulin and chromosomes. Oocytes will be imaged using confocal microscope to perform high resolution imaging and quantitative image analysis. The length, position and orientation of the second meiotic spindle will be quantifying. The actin network and chromosomes will be analyzed quantitatively. All measurements will be compared with fresh Metaphase-II oocytes used as a control group.

The first asymmetric division is highly error prone. To investigate whether chromosomes are segregated accurately after vitrification, we will perform Fluorescence In Situ Hybridization to paint each chromosome after chromosome spread from Metaphase-II stage oocytes from both conditions

A staining with Lectin will be used to mark cortical granules of matured oocytes from both protocols to observe whether the vitrification does modify their spatial distribution. To analyze this staining, we will use quantitative image analysis method.

Maternal factors stored in the oocyte cytoplasm during oogenesis as proteins and transcripts are essential for the early embryonic development. To know if the stock of maternal factors is diminished by the vitrification procedure, we will perform Reverse Transcription combined with Real Time PCR to quantify transcript amounts of candidates genes selected from human oocytes databases.

Origio A/S

University Hospital, Clermont-Ferrand

Patients requiring IVF treatment with PCOS or a PCO pattern in their ovaries who wish to undertake IVM (as a variant of their IVF procedure)

Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization

in vitro maturation of oocytes

Bruce I Rose, MD, PhD

Samuel Brown, MD

Julius Varzoni, BS

Meaghan German, RN

A protocol was developed to improve pregnancy results after IVM compared to results from studies in the literature. Differences from most published protocols include the use of the Steiner-Tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of FSH, and delayed embryo transfer during subsequent warmed cryo-preserved embryo transfer. Eligible patient have a PCO pattern in their ovaries during transvaginal ultrasound.

All participants are candidates for IVF having PCOS or having PCO patterns in their ovaries who wish to undertake IVM for the potential advantages that it holds. All cycles are proceeded by oral contraceptive use for cycle scheduling purposes. Priming is done with oral letrozole with the addition of 25-75 IU daily starting after 2 days of letrozole. HCG is given when several follicle have diameters 8 mm or greater and no follicles have diameters greater than 13 mm. Oocyte retrieval is done approximately 38 hours later. A Steiner-Tan needle is used for oocyte retrieval in a manner that minimizes the amount of time that an oocyte is out of the ovary and not in a controlled laboratory environment. Oocytes are assessed for maturity for up to 48 hours post retrieval. If mature, oocytes are injected with sperm using ICSI. Embryos are grown to blastocysts and all blastocyst are vitrified. Warmed cryo-preserved blastocyst are transferred using routine IVF protocols during a subsequent cycle.

IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer

A Prospective Series of IVF Cases Utilizing in Vitro Maturation (IVM) With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Embryo Transfer Using a Subsequent Frozen Embryo Transfer Cycle

Number of clinical pregnancies from all blastocyst transfers related to the retrieval

Number of ongoing pregnancies from blastocyst transfers related to the retrieval

ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy

pregnancy with cardiac activity (by history or observations) after 12 weeks

proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval

proportion of mature oocytes which display pronuclei

proportion of fertilized oocytes which become 2 or more cells

proportion of fertilized oocytes which form a fluid filled cavity

proportion of patients with an hCG level greater than 5 measured post first transfer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)	NCT01237106	Polycystic Ovar...	IVM	18 Years - 34 Years	University Reproductive Associates
In Vitro Maturation (IVM) of Human Oocytes	NCT01843569	Polycystic Ovar... Patients Sensit... Ovarian Hyper S...	In Vitro matura...	25 Years - 42 Years	Northwell Health
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)	NCT01237106	Polycystic Ovar...	IVM	18 Years - 34 Years	University Reproductive Associates
In Vitro Maturation (IVM) of Human Oocytes	NCT01843569	Polycystic Ovar... Patients Sensit... Ovarian Hyper S...	In Vitro matura...	25 Years - 42 Years	Northwell Health
Comparison of Vitrification Effect Before or After In Vitro Maturation	NCT03416400	Oocytes Vitrifi... Oocytes Matured...	Oocyte vitrific...	18 Years - 37 Years	University Hospital, Clermont-Ferrand
In Vitro Maturation (IVM) of Human Oocytes	NCT01843569	Polycystic Ovar... Patients Sensit... Ovarian Hyper S...	In Vitro matura...	25 Years - 42 Years	Northwell Health
IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer	NCT04149496	Polycystic Ovar...	in vitro matura...	18 Years - 38 Years	Brown Fertility
IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer	NCT04149496	Polycystic Ovar...	in vitro matura...	18 Years - 38 Years	Brown Fertility

Spots Global Cancer Trial Database for in vitro maturation