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

Phase 4

• Conditions: Endometrial Thickness; Pregnancy Outcome
• Interventions: Drug: HCG (human chorionic gonadotropin)

• Registration Number: NCT01768247
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2013-01
• Study First Submitted: 2013-01-12
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-15
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCG priming	HCG (human chorionic gonadotropin)	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

Primary Outcome Measures

Name	Time	Method
Endometrial thickness	14 days after estrogen treatment	measured by transvaginal ultrasound

Secondary Outcome Measures

Name	Time	Method
Pregnancy outcome	5 weeks after embryotransfer	Clinical pregnancy

Trial Locations

Locations (1)

HRG Foundation; 🇬🇷 Thessaloniki, Kalamaria, Greece