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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Papanikolaou Evangelos, Universitair Ziekenhuis Brussel.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: January 15, 2013
Last Update Posted: January 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Human Reproduction & Genetics Foundation
Information provided by (Responsible Party):
Papanikolaou Evangelos, Universitair Ziekenhuis Brussel

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: Intervention Model: Single Group Assignment
Masking: None (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 Papanikolaou Evangelos, Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Endometrial thickness [ Time Frame: 14 days after estrogen treatment ]
    measured by transvaginal ultrasound

Secondary Outcome Measures:
  • Pregnancy outcome [ Time Frame: 5 weeks after embryotransfer ]
    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.

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768247

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

Additional Information:
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
First Submitted: January 12, 2013
First Posted: January 15, 2013
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by Papanikolaou Evangelos, Universitair Ziekenhuis Brussel:
frozen cycles

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs