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

Pregnancy Outcome Clinical Trial

Official title:

HCG Priming for Thin Endometrium in IVF

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01768247
• Other study ID #: THINENDOM001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 12, 2013
• Last updated: January 16, 2013
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2013
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Abnormal uterine cavity in Hysteroscopy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Thickness
• Pregnancy Outcome

Intervention

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

Locations

Country	Name	City	State
Greece	HRG Foundation	Thessaloniki	Kalamaria

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Human Reproduction & Genetics Foundation

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Shufaro Y, Simon A, Laufer N, Fatum M. Thin unresponsive endometrium--a possible complication of surgical curettage compromising ART outcome. J Assist Reprod Genet. 2008 Aug;25(8):421-5. doi: 10.1007/s10815-008-9245-y. Epub 2008 Sep 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial thickness	measured by transvaginal ultrasound	14 days after estrogen treatment	No
Secondary	Pregnancy outcome	Clinical pregnancy	5 weeks after embryotransfer	No

External Links

•   Facility web page