HCG (Human Chorionic Gonadotropin) Priming for Thin Endometrium in IVF (in Vitro Fertilization)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Human Reproduction & Genetics Foundation
Information provided by (Responsible Party):
Papanikolaou Evangelos, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01768247
First received: January 12, 2013
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

A thin endometrium is one of the most difficult problems encountered in assisted reproduction every day practice Regarding the proliferative phase, several ways of treatment have been undertaken to circumvent thin endometrium trying to increase thickness with questionable results.

The objective of the current study will be whether a daily dose of 150 IU (international units) of human chorionic gonadotropin (HCG) for seven days concomitant with estrogen administration in estrogen replacement cycles can increase the endometrial thickness and improve pregnancy outcome.


Condition Intervention Phase
Endometrial Thickness
Pregnancy Outcome
Drug: HCG (human chorionic gonadotropin)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HCG Priming for Thin Endometrium in IVF

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Endometrial thickness [ Time Frame: 14 days after estrogen treatment ] [ Designated as safety issue: No ]
    measured by transvaginal ultrasound


Secondary Outcome Measures:
  • Pregnancy outcome [ Time Frame: 5 weeks after embryotransfer ] [ Designated as safety issue: No ]
    Clinical pregnancy


Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCG priming
Patients in this arm after 7-9 days of estrogen replacement they will receive a 150 international units (IU) HCG every day for 7 days concomitantly with the estradiol
Drug: HCG (human chorionic gonadotropin)
150 international units (IU) of HCG for seven days subcutaneously concomitantly with estrogens in preparation endometrium cycles fro frozen embryos replacement

Detailed Description:

In this pilot study subjects with repeatedly resistant thin endometrium, less than 6mm, will be recruited. The investigators sought to investigate the possible role of adding low dose HCG in the follicular phase, on the endometrial growth and development. The investigators constructed this hypothesis based on the fact that LH/HCG (luteinizing hormone/human chorionic gonadotropin) receptor is present in endometrium and therefore a positive interaction could be anticipated when HCG is administered in the proliferative phase of endometrial growth. Furthermore, in a previous study, where human menopausal gonadotropin (hMG) -well known that renders its luteinizing hormone (LH) capacity due to low dose HCG contain- was compared to recombinant-follicular stimulating hormone (rec-FSH) during ovarian stimulation, endometrium was more likely to be iso-echogenic and hypo-echogenic in the hMG group, also anticipating a possible positive role of HCG activity.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) Less than 6mm endometrial thickness before, (2) at least two failed implantations before

Exclusion Criteria:

  • Abnormal uterine cavity in Hysteroscopy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768247

Locations
Greece
HRG Foundation
Thessaloniki, Kalamaria, Greece, 55133
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Human Reproduction & Genetics Foundation
Investigators
Principal Investigator: Papanikolaou Evangelos, MD HRG clinical director
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Papanikolaou Evangelos, MD,PHD, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01768247     History of Changes
Other Study ID Numbers: THINENDOM001
Study First Received: January 12, 2013
Last Updated: January 16, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Universitair Ziekenhuis Brussel:
endometrium
thickness
pregnancy
HCG
frozen cycles

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014