Endometrial ThicknessPhase 4NCT01768247
HCG (Human Chorionic Gonadotropin) Priming for Thin Endometrium in IVF (in Vitro Fertilization)
A Phase 4 study testing HCG (human chorionic gonadotropin) in people with Endometrial Thickness and Pregnancy Outcome, run by Universitair Ziekenhuis Brussel at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Endometrial Thickness, Pregnancy Outcome
- What is being tested?
- HCG (human chorionic gonadotropin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2012to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (1) Less than 6mm endometrial thickness before, (2) at least two failed implantations before
Who cannot join
- Abnormal uterine cavity in Hysteroscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HCG Priming for Thin Endometrium in IVF
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.
Read the 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.
- Conditions
- Endometrial Thickness, Pregnancy Outcome
- Being tested
- HCG (human chorionic gonadotropin)
- Keywords
- endometrium, thickness, pregnancy, HCG, frozen cycles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HCG (human chorionic gonadotropin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness
measured by transvaginal ultrasound
Measured: 14 days after estrogen treatment
Secondary outcomes (1)
Pregnancy outcome
Clinical pregnancy
Measured: 5 weeks after embryotransfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endometrial ThicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Human Reproduction & Genetics Foundation
- Responsible party
- Principal investigator, Papanikolaou Evangelos, Universitair Ziekenhuis Brussel
- Investigators
- Papanikolaou Evangelos, MD, Principal investigator, HRG clinical director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768247
- Sponsor's protocol ID
- THINENDOM001
- Status last verified
- Jan 2013
- First submitted
- 12 Jan 2013
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18797990Papanikolaou 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.
PubMed 23949214
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HCG Priming for Thin Endometrium in IVF
- ClinicalTrials.gov ID
- NCT01768247
- Acronym / sponsor ID
- THINENDOM001
- Conditions
- Endometrial Thickness, Pregnancy Outcome
- Keywords
- endometrium, thickness, pregnancy, HCG, frozen cycles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Human Reproduction & Genetics Foundation
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCG priming | Experimental | Drug: 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 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) Less than 6mm endometrial thickness before, (2) at least two failed implantations before
Key exclusion criteria (1 listed)
- Abnormal uterine cavity in Hysteroscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | HCG priming |
Primary outcome
Endometrial thickness
Time frame: 14 days after estrogen treatment
measured by transvaginal ultrasound
1 secondary outcome
Pregnancy outcome
Time frame: 5 weeks after embryotransfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
- Background: PubMed 18797990Shufaro 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.
- Derived from this study: PubMed 23949214Papanikolaou 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.
- Facility web pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Papanikolaou Evangelos, MD principal investigator
HRG clinical director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HCG (human chorionic gonadotropin) in people with Endometrial Thickness and Pregnancy Outcome, run by Universitair Ziekenhuis Brussel at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial thickness (time frame: 14 days after estrogen treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01768247, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.