Clinical trial NCT01768247: HCG (Human Chorionic Gonadotropin) Priming for Thin Endometrium in IVF (in Vitro Fertilization)
Official title: HCG Priming for Thin Endometrium in IVF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endometrial Thickness
Pregnancy Outcome
Keywords: endometrium
thickness
pregnancy
HCG
frozen cycles
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Human Reproduction & Genetics Foundation
First posted: 2013-01-15
Enrollment: 15
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Abnormal uterine cavity in Hysteroscopy

Primary outcomes:
measure: Endometrial thickness
timeFrame: 14 days after estrogen treatment
Secondary outcomes:
measure: Pregnancy outcome
timeFrame: 5 weeks after embryotransfer
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: HRG Foundation
state: Kalamaria
Study officials:
affiliation: HRG clinical director
name: Papanikolaou Evangelos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Papanikolaou EG, Kyrou D, Zervakakou G, Paggou E, Humaidan P. "Follicular HCG endometrium priming for IVF patients experiencing resisting thin endometrium. A proof of concept study". J Assist Reprod Genet. 2013 Oct;30(10):1341-5. doi: 10.1007/s10815-013-0076-0. Epub 2013 Aug 16.