Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01843569
Status:
WITHDRAWN
Last Update Posted:
2020-11-16
First Post:
2013-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In Vitro Maturation (IVM) of Human Oocytes
Sponsor:
Northwell Health
Organization:
Study Overview
Official Title:
In Vitro Maturation (IVM) of Human Oocytes
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Institutional approval of study has expired.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVM
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.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: