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

NCT01768247 | Unknown Phase 4

• 1 other identifier: THINENDOM001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Thickness; Pregnancy Outcome

Keywords

endometrium; thickness; pregnancy; HCG; frozen cycles

Outcome Measures

Primary Outcomes (1)

• Endometrial thickness

  measured by transvaginal ultrasound

  14 days after estrogen treatment

Secondary Outcomes (1)

• Pregnancy outcome

  5 weeks after embryotransfer

Study Arms (1)

HCG priming

EXPERIMENTAL

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)

Interventions

HCG (human chorionic gonadotropin) DRUG

150 international units (IU) of HCG for seven days subcutaneously concomitantly with estrogens in preparation endometrium cycles fro frozen embryos replacement

HCG priming

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Abnormal uterine cavity in Hysteroscopy

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Human Reproduction & Genetics Foundation: collaborator

Study Sites (1)

HRG Foundation

Thessaloniki, Kalamaria, 55133, Greece

Location

Related Publications (2)

• 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.

  PMID: 18797990 BACKGROUND

• 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.

  PMID: 23949214 DERIVED

Related Links

• Facility web page

MeSH Terms

Interventions

Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Papanikolaou Evangelos, MD

  HRG clinical director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PHD

Study Record Dates

• First Submitted: January 12, 2013
• First Posted: January 15, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

GR (1)