Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF

NCT01202643 | Terminated Phase 1 Results DMC

• 1 other identifier: 09012010-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of G-CSF on endometrial thickness in women who have failed reaching minimal endometrial thickness by standard treatments, to assess how many reach embryo transfer and what implantation and pregnancy rates are in comparison to control patients. The study will be conducted in women undergoing transfer of previously cryopreserved embryos or undergoing transfer of embryos from donor eggs.

Conditions

Infertility, Female

Keywords

Thin Endometrium; Asherman's Syndrome; Endometrial Scarring

Outcome Measures

Primary Outcomes (1)

• Endometrial Thickness

  Thickness of the endometrium on the day of embryo transfer

  Day of embryo transfer

Secondary Outcomes (1)

• Implantation Rate

  28 days after embryo transfer

Study Arms (2)

G-CSF

EXPERIMENTAL

G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation

Drug: G-CSF

Saline

PLACEBO COMPARATOR

Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation

Drug: Saline

Interventions

G-CSF DRUG

One infusion of G-CSF 300 units administered by intrauterine infusion

Also known as: NEUPOGEN (Filgrastim)

G-CSF

Saline DRUG

One intrauterine saline infusions of 1 cc

Also known as: Normal Saline (Salt water), 0.91% w/v of NaCl, about 300 mOsm/L

Saline

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient's preparing for invitro fertilization and embryo transfer with endometrial growth of less than 7 mm, unresponsive to standard treatment

You may not qualify if:

• Sickle Cell disease
• Renal insufficiency
• Upper respiratory infection or Pneumonia
• Chronic Neutropenia
• Known Past or present malignancy

Sponsors & Collaborators

• Center for Human Reproduction: lead
• Foundation for Reproductive Medicine: collaborator

Study Sites (1)

Center for Human Reproduction

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Infertility, Female; Gynatresia

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. David Barad
• Organization: Center for Human Reproduction

dbarad@theCHR.com

212 994-4400

Study Officials

• David H Barad, MD, MS

  Center for Human Reproduction

  PRINCIPAL INVESTIGATOR

• Norbert Gleicher, MD

  Center for Human Reproduction

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 26, 2019
• Results First Posted: December 4, 2014

Record last verified: 2019-07

Locations

US (1)