In Vitro Maturation (IVM) of Human Oocytes

NCT01843569 | Withdrawn

• 1 other identifier: 12-364A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovarian Syndrome (PCOS); Patients Sensitive to Exogenous Gonadotropins; Ovarian Hyper Stimulation Syndrome (OHSS)

Keywords

In Vitro Maturation; IVM; Natural cycle IVF; PCOS

Outcome Measures

Primary Outcomes (3)

• Pregnancy

  Establishment of a successful pregnancy

  1 month

• Implantation

  fetal hearts per embryo replaced

  1 month

• live birth rates

  9 months

Secondary Outcomes (10)

• Multiple pregnancy and miscarriage rates

  9 months

• Neonatal outcomes

  9 months

• Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH])

  2 weeks

• Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment

  2 weeks

• Number and quality of oocytes retrieved

  1 day

Study Arms (1)

IVM

EXPERIMENTAL

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

Biological: In Vitro maturation

Interventions

In Vitro maturation BIOLOGICAL

IVM

Eligibility Criteria

• Age: 25 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Each subject must be female.
• Each subject must have an indication for COH and IVF or ICSI.
• Each subject must be willing and able to provide written informed consent for the trial.
• Each subject must be ≤42 years of age at the time of signing informed consent.
• 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.

You may not qualify if:

• Subject with premature ovarian failure.
• Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction.
• Subject with malformation or absence of uterus.
• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

The Center for Human Reproduction

Manhasset, New York, 11030, United States

Location

Related Publications (5)

• Practice Committee of the American Society for Reproductive Medicine (ASRM). Committee opinion: In Vitro Maturation. Fertil & Steril. Ready for member review 2/21/12. Not yet in print.

  BACKGROUND

• Le Du A, Kadoch IJ, Bourcigaux N, Doumerc S, Bourrier MC, Chevalier N, Fanchin R, Chian RC, Tachdjian G, Frydman R, Frydman N. In vitro oocyte maturation for the treatment of infertility associated with polycystic ovarian syndrome: the French experience. Hum Reprod. 2005 Feb;20(2):420-4. doi: 10.1093/humrep/deh603. Epub 2004 Nov 4.

  PMID: 15528263 BACKGROUND

• Chian RC, Buckett WM, Tan SL. In-vitro maturation of human oocytes. Reprod Biomed Online. 2004 Feb;8(2):148-66. doi: 10.1016/s1472-6483(10)60511-1.

  PMID: 14989791 BACKGROUND

• Jurema MW, Nogueira D. In vitro maturation of human oocytes for assisted reproduction. Fertil Steril. 2006 Nov;86(5):1277-91. doi: 10.1016/j.fertnstert.2006.02.126. Epub 2006 Sep 25.

  PMID: 16996508 BACKGROUND

• Buckett WM, Chian RC, Holzer H, Dean N, Usher R, Tan SL. Obstetric outcomes and congenital abnormalities after in vitro maturation, in vitro fertilization, and intracytoplasmic sperm injection. Obstet Gynecol. 2007 Oct;110(4):885-91. doi: 10.1097/01.AOG.0000284627.38540.80.

  PMID: 17906024 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

In Vitro Oocyte Maturation Techniques

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Avner Hershlag, MD

  NSLIJ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: April 30, 2013
• Study Start: January 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

US (1)