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

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. Identifier: NCT01768247
Recruitment Status : Unknown
Verified January 2013 by Papanikolaou Evangelos, Universitair Ziekenhuis Brussel.
Recruitment status was:  Active, not recruiting
First Posted : January 15, 2013
Last Update Posted : January 17, 2013
Human Reproduction & Genetics Foundation
Information provided by (Responsible Party):
Papanikolaou Evangelos, Universitair Ziekenhuis Brussel

Brief Summary:

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 or disease Intervention/treatment Phase
Endometrial Thickness Pregnancy Outcome Drug: HCG (human chorionic gonadotropin) Phase 4

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HCG Priming for Thin Endometrium in IVF
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Pregnancy outcome [ Time Frame: 5 weeks after embryotransfer ]
    Clinical pregnancy

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT01768247

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HRG Foundation
Thessaloniki, Kalamaria, Greece, 55133
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Human Reproduction & Genetics Foundation
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Principal Investigator: Papanikolaou Evangelos, MD HRG clinical director
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Papanikolaou Evangelos, MD,PHD, Universitair Ziekenhuis Brussel Identifier: NCT01768247    
Other Study ID Numbers: THINENDOM001
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013
Keywords provided by Papanikolaou Evangelos, Universitair Ziekenhuis Brussel:
frozen cycles
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs