Gene AbnormalityNCT04175002
Endometrial Heparin-binding Epidermal Growth Factor Expression
An observational study of Gene Abnormality, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Women with PCOS comprise a majority of fertility clinic attendees. Unfortunately, a high failure rate following fertility treatment was observed especially in obese women due to implantation failure. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gene Abnormality
- What is being tested?
- utrogestan
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2019to 31 Jul 2020
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This prospective study is going to be performed at UKM Medical Centre for a duration of 1 years. The PCOS and control women will be recruited from the Medically Assisted clinic in Obstetrics \& Gynaecology department. Patients will be recruited following written consent. Background information such as age, race, parity, menstrual pattern, associated symptoms will be taken. Clinical assessment which includes height, weight, body mass index and hirsutism (determined by a modified Ferriman and Gallwey score) will be performed. The serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), total testosterone (TT), cortisol, prolactin (PRL), dehydroepiandrosterone sulfate (DHEAS), and β-human chorionic gonadotropin (β-hCG) are measured for all participants. A transvaginal ultrasound scan of the ovaries will be obtained. Endometrial samples are obtained using the Pipelle de Cornier catheter for all participant
The inclusion criteria for the study group are:
- All patients between the aged of 18 to 40 years.
- Women diagnosed with polycystic ovarian syndrome fulfilling two out of three Rotterdam criteria (ie, oligo- or anovulation, hyperandrogenism, and polycystic ovaries on ultrasound).
- Healthy volunteer with confirmed fertility (having at least one child previously), with a normal level of basic reproductive hormones and regular interval of the menstrual cycle (26 to 32 days). (Control group)
The exclusion criteria are:
- Smoking
- any hormonal treatment or other drugs to treat anovulation for at least 3 months before the study
- Pregnancy or lactation during the preceding 12 months
- Systemic disease such as endocrine or eating disorders besides PCOS
- Diagnosed with a uterine or ovarian disease.
- Any regular medication such as hormones, herbal substance, statins or corticoids for at least 3 months before the study.
- History of intrauterine device placement.
The inclusion criteria for the control group are:
- All patients between the aged of 18 to 40 years.
- Healthy volunteer with confirmed fertility (having at least one child previously), with a normal level of basic reproductive hormones and regular interval of the menstrual cycle (26 to 32 days).
The exclusion criteria are:
- Smoking
- any hormonal treatment or other drugs to treat anovulation for at least 3 months before the study
- Pregnancy or lactation during the preceding 12 months
- Systemic disease such as endocrine or eating disorders besides PCOS
- Diagnosed with a uterine or ovarian disease.
- Any regular medication such as hormones, herbal substance, statins or corticoids for at least 3 months before the study.
- History of intrauterine device placement.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Medically Assisted clinic in Obstetrics & Gynaecology department, UKM Medical Centre
Cheras, Kuala Lumpur, 56000
Muhammad azrai abu, Medical degree, 60196410944, azraiabu1983@gmail.com
About this study
Official title: Endometrial Heparin-binding Epidermal Growth Factor Expression in Implantation Window of Obese Women With Polycystic Ovarian Syndrome(PCOS)
Women with PCOS comprise a majority of fertility clinic attendees. Unfortunately, a high failure rate following fertility treatment was observed especially in obese women due to implantation failure. The local study on PCOS women has shown significant changes in an endometrial tumor - regulatory genes but not focusing on the endometrial implantation failure. Many previous attempts using human chorionic gonadotrophin (HCG) infused embryo, gonadotrophin agonist therapy or progesterone support aiming to improve implantation failure in the assisted reproductive technique still unable to enhance pregnancy rate beyond 40% despite a higher' fertilization rate up to 95%. There is still a research gap on what makes obese PCOS women prone to coincides with implantation failure. Endometrial component related to the expression of growth factors play an integral role in establishing cellular context necessary for successful pregnancy. Thus, a new fundamental knowledge on endometrial specific heparin-binding epidermal growth factor expression in the obese PCOS women is vitally important, not only to predict implantation failure but a potential therapy to improve pregnancy outcome.
Read the detailed description
This prospective study is going to be performed at UKM Medical Centre for a duration of 1 year. The PCOS and control women will be recruited from the Medically Assisted clinic in Obstetrics \& Gynaecology department.
The sample size of this study is calculated using Power and Sample Size Calculator by Dupont \& Plummer 1998 for paired t-test response version 3.1.2; using the endpoint of mean of Hb-EGF expression during window of implantation in predicting successful pregnancy following in vitro fertilization (IVF) rate by Mengling et al. 2016 (11) as one of its specific outcome. The auto-generated sample size using this programme is 8 subjects. Considering the dropout rate of the sample is 30%, the total sample size required in this study is 10 subjects each arm, making a total sample size 40.
The participants are divided into four groups according to PCOS diagnosis and Asian adult population body mass index (BMI):
- Anovulatory PCOS women with a BMI greater than 27 (OB-PCOS)
- Anovulatory PCOS women with a BMI lower than 25 (NW-PCOS)
- Healthy fertile women with a BMI greater than 27 (OB-C)
- Healthy fertile women with a BMI lower than 25 (NW-C)
In the PCOS group, generally anovulatory cycle hence the implantation window during mid-secretory endometrium can be exhibit following a daily oral micronized progesterone (Utrogestan 200mg) for 10 days based on previously published methods.
Volunteers in the control group with a normal regular menses will be counseled regarding the procedure and monitored for ovulation. The endometrial biopsy will be acquired during implantation window (mid-secretory endometrium), which occurred 7-9 days after the ultrasound and urinary LH confirmed ovulation.
Endometrial samples are obtained using the Pipelle de Cornier catheter for all participants. The endometrium sample that is taken is divided into two portions; a portion for histopathological examination (HPE) for endometrial dating and a portion frozen in liquid nitrogen at -80 degrees Celsius for real-time PCR analysis.
For endometrial dating, all samples were analyzed by classical histological analysis according to the criteria of Noyes.
A total amount of RNA was isolated from the endometrial tissue using RNA easy kit by following manufacturer's instruction. Pellet will be suspended in 30ul of RNAase-DNAse free water. Finally, nanodrop will be used to determine the concentration and quality of RNA. By following manufacture's instruction, total RNA will be reversed transcribed to cDNA. The target for cDNA is primers for heparin binding epidermal growth factor. QRT-PCR will be performed using Sybergreen Master Mix and detected using QRT-PCR detector machine in accordance with manufacturer's protocols. The reaction was running in real-time PCR machine with 40 cycles and cycling temperature as follows: 95 ºC for 10 minutes and 15 seconds, 56 ºC for 30 seconds and final dissociation stage: 94 ºC for 15 seconds, 56 ºC for 15 seconds and last 95 ºC for 15 seconds. Relative quantification will be calculated by normalizing against any housekeeping genes available. Positive controls and negative controls will be included in each analysis run.
- Conditions
- Gene Abnormality
- Being tested
- utrogestan
- Keywords
- heparin-binding epidermal growth factor, polycystic ovarian syndrome, implantation window, obese
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
utrogestanDrug
oral uterogeston 200mg daily to achieve window of implantation from previous study
| Study group | Role | What they receive |
|---|---|---|
| Anovulatory PCOS women with a BMI greater than 27 | Not described Receives: Drug: utrogestan | |
| Anovulatory PCOS women with a BMI lower than 25 | Not described Receives: Drug: utrogestan | |
| Healthy fertile women with a BMI greater than 27 | Not described | |
| Healthy fertile women with a BMI lower than 25 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Heparin-binding Epidermal Growth Factor Expression
For obese and normal BMI PCOS window of implantation based on Noyes criteria
Measured: After 10 days of oral uterogeston 20mg daily
Endometrial Heparin-binding Epidermal Growth Factor Expression
For obese and normal BMI normal fertile women window of implantation based on Noyes criteria
Measured: After 5 days of positive urinary LH
Secondary outcomes (1)
Hormonal assay
Measured: During day 2-6 of menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Aug 2019
- Primary completion31 May 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Gene AbnormalityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azrai Abu, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175002
- Sponsor's protocol ID
- UKM PPI.800-1/1/5/JEP-2019-367
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mengling S, Xian X, Yongli L, et al. Expression of heparin-binding epidermal growth factor in the endometrium is positively correlated with IVF-ET pregnancy outcome. Int J Clin Exp Pathol 2016;9(8):8280-8285.
Fauser BC, Tarlatzis BC, Rebar RW, Legro RS, Balen AH, Lobo R, Carmina E, Chang J, Yildiz BO, Laven JS, Boivin J, Petraglia F, Wijeyeratne CN, Norman RJ, Dunaif A, Franks S, Wild RA, Dumesic D, Barnhart K. Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group. Fertil Steril. 2012 Jan;97(1):28-38.e25. doi: 10.1016/j.fertnstert.2011.09.024. Epub 2011 Dec 6.
PubMed 22153789Joham AE, Boyle JA, Ranasinha S, Zoungas S, Teede HJ. Contraception use and pregnancy outcomes in women with polycystic ovary syndrome: data from the Australian Longitudinal Study on Women's Health. Hum Reprod. 2014 Apr;29(4):802-8. doi: 10.1093/humrep/deu020. Epub 2014 Feb 18.
PubMed 24549213Bellver J, Martinez-Conejero JA, Labarta E, Alama P, Melo MA, Remohi J, Pellicer A, Horcajadas JA. Endometrial gene expression in the window of implantation is altered in obese women especially in association with polycystic ovary syndrome. Fertil Steril. 2011 Jun;95(7):2335-41, 2341.e1-8. doi: 10.1016/j.fertnstert.2011.03.021. Epub 2011 Apr 9.
PubMed 21481376Schulte MM, Tsai JH, Moley KH. Obesity and PCOS: the effect of metabolic derangements on endometrial receptivity at the time of implantation. Reprod Sci. 2015 Jan;22(1):6-14. doi: 10.1177/1933719114561552. Epub 2014 Dec 7.
PubMed 25488942DeUgarte DA, DeUgarte CM, Sahakian V. Surrogate obesity negatively impacts pregnancy rates in third-party reproduction. Fertil Steril. 2010 Feb;93(3):1008-10. doi: 10.1016/j.fertnstert.2009.07.1005. Epub 2009 Sep 5.
PubMed 19733847Piltonen TT. Polycystic ovary syndrome: Endometrial markers. Best Pract Res Clin Obstet Gynaecol. 2016 Nov;37:66-79. doi: 10.1016/j.bpobgyn.2016.03.008. Epub 2016 Apr 1.
PubMed 27156350Large MJ, Wetendorf M, Lanz RB, Hartig SM, Creighton CJ, Mancini MA, Kovanci E, Lee KF, Threadgill DW, Lydon JP, Jeong JW, DeMayo FJ. The epidermal growth factor receptor critically regulates endometrial function during early pregnancy. PLoS Genet. 2014 Jun 19;10(6):e1004451. doi: 10.1371/journal.pgen.1004451. eCollection 2014 Jun.
PubMed 24945252Lim HJ, Dey SK. HB-EGF: a unique mediator of embryo-uterine interactions during implantation. Exp Cell Res. 2009 Feb 15;315(4):619-26. doi: 10.1016/j.yexcr.2008.07.025. Epub 2008 Aug 3.
PubMed 18708050Jessmon P, Leach RE, Armant DR. Diverse functions of HBEGF during pregnancy. Mol Reprod Dev. 2009 Dec;76(12):1116-27. doi: 10.1002/mrd.21066.
PubMed 19565643Wirstlein PK, Mikolajczyk M, Skrzypczak J. Correlation of the expression of heparanase and heparin-binding EGF-like growth factor in the implantation window of nonconceptual cycle endometrium. Folia Histochem Cytobiol. 2013;51(2):127-34. doi: 10.5603/FHC.2013.0020.
PubMed 23907942Zang H, Sahlin L, Masironi B, Eriksson E, Linden Hirschberg A. Effects of testosterone treatment on endometrial proliferation in postmenopausal women. J Clin Endocrinol Metab. 2007 Jun;92(6):2169-75. doi: 10.1210/jc.2006-2171. Epub 2007 Mar 6.
PubMed 17341565Hulchiy M, Nybacka A, Sahlin L, Hirschberg AL. Endometrial Expression of Estrogen Receptors and the Androgen Receptor in Women With Polycystic Ovary Syndrome: A Lifestyle Intervention Study. J Clin Endocrinol Metab. 2016 Feb;101(2):561-71. doi: 10.1210/jc.2015-3803. Epub 2015 Dec 9.
PubMed 26649621Apparao KB, Lovely LP, Gui Y, Lininger RA, Lessey BA. Elevated endometrial androgen receptor expression in women with polycystic ovarian syndrome. Biol Reprod. 2002 Feb;66(2):297-304. doi: 10.1095/biolreprod66.2.297.
PubMed 11804942Hamid FA, Mokhtar MH, Abdul Karim AK, Ahmad MF, Abd Aziz NH, Abdul Wahab AY, Abu MA. Obesity results in lower integrin expression in women with polycystic ovarian syndrome during the window of implantation. Front Endocrinol (Lausanne). 2025 Oct 21;16:1590716. doi: 10.3389/fendo.2025.1590716. eCollection 2025.
PubMed 41195204
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Heparin-binding Epidermal Growth Factor Expression in Implantation Window of Obese Women With Polycystic Ovarian Syndrome(PCOS)
- ClinicalTrials.gov ID
- NCT04175002
- Acronym / sponsor ID
- UKM PPI.800-1/1/5/JEP-2019-367
- Conditions
- Gene Abnormality
- Keywords
- heparin-binding epidermal growth factor, polycystic ovarian syndrome, implantation window, obese
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 22 Nov 2019 (actual)
- 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.
Women with PCOS comprise a majority of fertility clinic attendees. Unfortunately, a high failure rate following fertility treatment was observed especially in obese women due to implantation failure. The local study on PCOS women has shown significant changes in an endometrial tumor - regulatory genes but not focusing on the endometrial implantation failure. Many previous attempts using human chorionic gonadotrophin (HCG) infused embryo, gonadotrophin agonist therapy or progesterone support aiming to improve implantation failure in the assisted reproductive technique still unable to enhance pregnancy rate beyond 40% despite a higher' fertilization rate up to 95%. There is still a research gap on what makes obese PCOS women prone to coincides with implantation failure. Endometrial component related to the expression of growth factors play an integral role in establishing cellular context necessary for successful pregnancy. Thus, a new fundamental knowledge on endometrial specific heparin-binding epidermal growth factor expression in the obese PCOS women is vitally important, not only to predict implantation failure but a potential therapy to improve pregnancy outcome.
Detailed description
This prospective study is going to be performed at UKM Medical Centre for a duration of 1 year. The PCOS and control women will be recruited from the Medically Assisted clinic in Obstetrics \& Gynaecology department.
The sample size of this study is calculated using Power and Sample Size Calculator by Dupont \& Plummer 1998 for paired t-test response version 3.1.2; using the endpoint of mean of Hb-EGF expression during window of implantation in predicting successful pregnancy following in vitro fertilization (IVF) rate by Mengling et al. 2016 (11) as one of its specific outcome. The auto-generated sample size using this programme is 8 subjects. Considering the dropout rate of the sample is 30%, the total sample size required in this study is 10 subjects each arm, making a total sample size 40.
The participants are divided into four groups according to PCOS diagnosis and Asian adult population body mass index (BMI):
- Anovulatory PCOS women with a BMI greater than 27 (OB-PCOS)
- Anovulatory PCOS women with a BMI lower than 25 (NW-PCOS)
- Healthy fertile women with a BMI greater than 27 (OB-C)
- Healthy fertile women with a BMI lower than 25 (NW-C)
In the PCOS group, generally anovulatory cycle hence the implantation window during mid-secretory endometrium can be exhibit following a daily oral micronized progesterone (Utrogestan 200mg) for 10 days based on previously published methods.
Volunteers in the control group with a normal regular menses will be counseled regarding the procedure and monitored for ovulation. The endometrial biopsy will be acquired during implantation window (mid-secretory endometrium), which occurred 7-9 days after the ultrasound and urinary LH confirmed ovulation.
Endometrial samples are obtained using the Pipelle de Cornier catheter for all participants. The endometrium sample that is taken is divided into two portions; a portion for histopathological examination (HPE) for endometrial dating and a portion frozen in liquid nitrogen at -80 degrees Celsius for real-time PCR analysis.
For endometrial dating, all samples were analyzed by classical histological analysis according to the criteria of Noyes.
A total amount of RNA was isolated from the endometrial tissue using RNA easy kit by following manufacturer's instruction. Pellet will be suspended in 30ul of RNAase-DNAse free water. Finally, nanodrop will be used to determine the concentration and quality of RNA. By following manufacture's instruction, total RNA will be reversed transcribed to cDNA. The target for cDNA is primers for heparin binding epidermal growth factor. QRT-PCR will be performed using Sybergreen Master Mix and detected using QRT-PCR detector machine in accordance with manufacturer's protocols. The reaction was running in real-time PCR machine with 40 cycles and cycling temperature as follows: 95 ºC for 10 minutes and 15 seconds, 56 ºC for 30 seconds and final dissociation stage: 94 ºC for 15 seconds, 56 ºC for 15 seconds and last 95 ºC for 15 seconds. Relative quantification will be calculated by normalizing against any housekeeping genes available. Positive controls and negative controls will be included in each analysis run.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anovulatory PCOS women with a BMI greater than 27 | – | Drug: utrogestan |
| Anovulatory PCOS women with a BMI lower than 25 | – | Drug: utrogestan |
| Healthy fertile women with a BMI greater than 27 | – | – |
| Healthy fertile women with a BMI lower than 25 | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This prospective study is going to be performed at UKM Medical Centre for a duration of 1 years. The PCOS and control women will be recruited from the Medically Assisted clinic in Obstetrics \& Gynaecology department. Patients will be recruited following written consent. Background information such as age, race, parity, menstrual pattern, associated symptoms will be taken. Clinical assessment which includes height, weight, body mass index and hirsutism (determined by a modified Ferriman and Gallwey score) will be performed. The serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), total testosterone (TT), cortisol, prolactin (PRL), dehydroepiandrosterone sulfate (DHEAS), and β-human chorionic gonadotropin (β-hCG) are measured for all participants. A transvaginal ultrasound scan of the ovaries will be obtained. Endometrial samples are obtained using the Pipelle de Cornier catheter for all participant
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 |
|---|---|---|
| utrogestanoral uterogeston 200mg daily to achieve window of implantation from previous study | Drug | Anovulatory PCOS women with a BMI greater than 27, Anovulatory PCOS women with a BMI lower than 25 |
Primary outcome
Endometrial Heparin-binding Epidermal Growth Factor Expression
Time frame: After 10 days of oral uterogeston 20mg daily
For obese and normal BMI PCOS window of implantation based on Noyes criteria
Endometrial Heparin-binding Epidermal Growth Factor Expression
Time frame: After 5 days of positive urinary LH
For obese and normal BMI normal fertile women window of implantation based on Noyes criteria
1 secondary outcome
Hormonal assay
Time frame: During day 2-6 of menstrual cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- BackgroundMengling S, Xian X, Yongli L, et al. Expression of heparin-binding epidermal growth factor in the endometrium is positively correlated with IVF-ET pregnancy outcome. Int J Clin Exp Pathol 2016;9(8):8280-8285.
- Results publication: PubMed 22153789Fauser BC, Tarlatzis BC, Rebar RW, Legro RS, Balen AH, Lobo R, Carmina E, Chang J, Yildiz BO, Laven JS, Boivin J, Petraglia F, Wijeyeratne CN, Norman RJ, Dunaif A, Franks S, Wild RA, Dumesic D, Barnhart K. Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group. Fertil Steril. 2012 Jan;97(1):28-38.e25. doi: 10.1016/j.fertnstert.2011.09.024. Epub 2011 Dec 6.
- Results publication: PubMed 24549213Joham AE, Boyle JA, Ranasinha S, Zoungas S, Teede HJ. Contraception use and pregnancy outcomes in women with polycystic ovary syndrome: data from the Australian Longitudinal Study on Women's Health. Hum Reprod. 2014 Apr;29(4):802-8. doi: 10.1093/humrep/deu020. Epub 2014 Feb 18.
- Results publication: PubMed 21481376Bellver J, Martinez-Conejero JA, Labarta E, Alama P, Melo MA, Remohi J, Pellicer A, Horcajadas JA. Endometrial gene expression in the window of implantation is altered in obese women especially in association with polycystic ovary syndrome. Fertil Steril. 2011 Jun;95(7):2335-41, 2341.e1-8. doi: 10.1016/j.fertnstert.2011.03.021. Epub 2011 Apr 9.
- Results publication: PubMed 25488942Schulte MM, Tsai JH, Moley KH. Obesity and PCOS: the effect of metabolic derangements on endometrial receptivity at the time of implantation. Reprod Sci. 2015 Jan;22(1):6-14. doi: 10.1177/1933719114561552. Epub 2014 Dec 7.
- Results publication: PubMed 19733847DeUgarte DA, DeUgarte CM, Sahakian V. Surrogate obesity negatively impacts pregnancy rates in third-party reproduction. Fertil Steril. 2010 Feb;93(3):1008-10. doi: 10.1016/j.fertnstert.2009.07.1005. Epub 2009 Sep 5.
- Results publication: PubMed 27156350Piltonen TT. Polycystic ovary syndrome: Endometrial markers. Best Pract Res Clin Obstet Gynaecol. 2016 Nov;37:66-79. doi: 10.1016/j.bpobgyn.2016.03.008. Epub 2016 Apr 1.
- Results publication: PubMed 24945252Large MJ, Wetendorf M, Lanz RB, Hartig SM, Creighton CJ, Mancini MA, Kovanci E, Lee KF, Threadgill DW, Lydon JP, Jeong JW, DeMayo FJ. The epidermal growth factor receptor critically regulates endometrial function during early pregnancy. PLoS Genet. 2014 Jun 19;10(6):e1004451. doi: 10.1371/journal.pgen.1004451. eCollection 2014 Jun.
- Results publication: PubMed 18708050Lim HJ, Dey SK. HB-EGF: a unique mediator of embryo-uterine interactions during implantation. Exp Cell Res. 2009 Feb 15;315(4):619-26. doi: 10.1016/j.yexcr.2008.07.025. Epub 2008 Aug 3.
- Results publication: PubMed 19565643Jessmon P, Leach RE, Armant DR. Diverse functions of HBEGF during pregnancy. Mol Reprod Dev. 2009 Dec;76(12):1116-27. doi: 10.1002/mrd.21066.
- Results publication: PubMed 23907942Wirstlein PK, Mikolajczyk M, Skrzypczak J. Correlation of the expression of heparanase and heparin-binding EGF-like growth factor in the implantation window of nonconceptual cycle endometrium. Folia Histochem Cytobiol. 2013;51(2):127-34. doi: 10.5603/FHC.2013.0020.
- Results publication: PubMed 17341565Zang H, Sahlin L, Masironi B, Eriksson E, Linden Hirschberg A. Effects of testosterone treatment on endometrial proliferation in postmenopausal women. J Clin Endocrinol Metab. 2007 Jun;92(6):2169-75. doi: 10.1210/jc.2006-2171. Epub 2007 Mar 6.
- Individual participant dataSharing planned: No
Related trials for Gene Abnormality
RecruitingObservational study
Genome Medical Sequencing for Gene Discovery
Intellectual Disabilities, Congenital Anomaly
RecruitingPhase 2
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
Lymphoma, Non-Hodgkin, Multiple Myeloma
Not yet recruitingPhase 1/2
Safety and Efficacy Study of GEB-101 Injection in Subjects With TGFBI-related Corneal Dystrophy
Hereditary Corneal Dystrophy, Corneal Abnormality
RecruitingPhase 2
A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations
Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation
RecruitingPhase 2
MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
Hematologic Malignancy, Acute Leukemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gene Abnormality, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Nov 2019. 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 Malaysia. 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.
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?
Contact Muhammad azrai abu, Medical degree (60196410944, azraiabu1983@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Heparin-binding Epidermal Growth Factor Expression (time frame: After 10 days of oral uterogeston 20mg daily). The study lists 2 primary outcomes in all. 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 NCT04175002, which also lists 15 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 22 Nov 2019.