Miscarriage, RecurrentNCT05437471
Effects of Co-treatment on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure
A study testing GNRH Analoge, Duphaston, Letrozole in people with Miscarriage, Recurrent, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
To compare the abv3-integrin expression in endometrium tissue among RIF women between the GnRH analogue with Aromatase Inhibitor (Group A) , GnRH analogue with progesterone (Group B) and GnRH analogue alone as control group (Group C) 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
- Miscarriage, Recurrent
- What is being tested?
- GNRH Analoge, Duphaston, Letrozole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2020to 30 May 2022
- Phase
- Interventional
- 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
Who may be able to join
- Women of 18 to 40 years of age
- No significant pre-existing major medical.
- Diagnosed as recurrent implantation failure - at least two or more failure of achieving pregnancy following embryo transfer (ET) despite the optimum endometrial thickness and good quality of embryo (unexplained).
- Regular menstrual cycle atleast 3 months prior to treatment
- Not taking any hormonal treatment for atlest 3months prior to recruitment
- Agreed to participate
Who cannot join
- Concurrent significant pre-existing major medical conditions such as uncontrolled diabetes, active systemic lupus erythematosus (SLE) or Anti Phospholipid Syndrome (APS) that will interfere with implantation.
- Poor quality of embryo
- Suboptimal endometrial thickness(<8mm) during the embryo transfer (ET).
- On hormonal therapy prior to recruitment.
- Not agreed to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Co-treatment With Aromatase Inhibitor or Progestin on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure
To compare the abv3-integrin expression in endometrium tissue among RIF women between the GnRH analogue with Aromatase Inhibitor (Group A) , GnRH analogue with progesterone (Group B) and GnRH analogue alone as control group (Group C)
Read the detailed description
- To determine the abv3-integrin expression isolated from endometrium tissue from women with RIF prior to medical therapy. ii. To determine the abv3-integrin expression isolated from endometrium tissue from Group A, Group B and Group C following the medical therapy. iii. To compare the abv3-integrin expression from endometrium tissue obtained from Group A, B and C following the medical therapy. iv. To compare the implantation rates among Group A, B and C following the medical therapy.
- To compare the ongoing pregnancy among Group A, B and C following the medical therapy
- Conditions
- Miscarriage, Recurrent
- Being tested
- GNRH Analoge, Duphaston, Letrozole
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNRH Analoge, Duphaston, LetrozoleDrug
GNRH Analoge, Duphaston, Letrozole
| Study group | Role | What they receive |
|---|---|---|
| Group A (GnRH analogue with Aromatase Inhibitor | Active comparator | This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed by Letroloze 10mg OD for 3 months Receives: Drug: GNRH Analoge, Duphaston, Letrozole |
| Group B (GnRH analogue with Progesterone | Active comparator | This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed Duphaston 10mg BD by for 3 months Receives: Drug: GNRH Analoge, Duphaston, Letrozole |
| Group C (GnRH analogue alone) | Placebo comparator | This is a control group. The candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) only. Receives: Drug: GNRH Analoge, Duphaston, Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial abv3-integrin expression expressions
pre and post treatment endometrial abv3-integrin expressions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Jan 2020
- Primary completion30 Dec 2021
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miscarriage, RecurrentStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All recruited women will be allocated in three groups, and endometrial tissue sampling will be obtained prior to medical intervention assigned during luteal phase depending on their menstrual cycle. All these women will be divided randomly in three groups A, B \& C equally by using the auto-randomized program in SPSS version 21.0.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thines Ramalingam, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437471
- Sponsor's protocol ID
- GGPM-2019-034
- Status last verified
- Jun 2022
- First submitted
- 29 Mar 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Co-treatment With Aromatase Inhibitor or Progestin on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT05437471
- Acronym / sponsor ID
- GGPM-2019-034
- Conditions
- Miscarriage, Recurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 29 Jun 2022 (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.
To compare the abv3-integrin expression in endometrium tissue among RIF women between the GnRH analogue with Aromatase Inhibitor (Group A) , GnRH analogue with progesterone (Group B) and GnRH analogue alone as control group (Group C)
Detailed description
- To determine the abv3-integrin expression isolated from endometrium tissue from women with RIF prior to medical therapy. ii. To determine the abv3-integrin expression isolated from endometrium tissue from Group A, Group B and Group C following the medical therapy. iii. To compare the abv3-integrin expression from endometrium tissue obtained from Group A, B and C following the medical therapy. iv. To compare the implantation rates among Group A, B and C following the medical therapy.
- To compare the ongoing pregnancy among Group A, B and C following the medical therapy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All recruited women will be allocated in three groups, and endometrial tissue sampling will be obtained prior to medical intervention assigned during luteal phase depending on their menstrual cycle. All these women will be divided randomly in three groups A, B \& C equally by using the auto-randomized program in SPSS version 21.0.
| Arm | Type | Receives |
|---|---|---|
| Group A (GnRH analogue with Aromatase Inhibitor | Active comparator | Drug: GNRH Analoge, Duphaston, LetrozoleThis group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed by Letroloze 10mg OD for 3 months |
| Group B (GnRH analogue with Progesterone | Active comparator | Drug: GNRH Analoge, Duphaston, LetrozoleThis group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed Duphaston 10mg BD by for 3 months |
| Group C (GnRH analogue alone) | Placebo comparator | Drug: GNRH Analoge, Duphaston, LetrozoleThis is a control group. The candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) only. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women of 18 to 40 years of age
- No significant pre-existing major medical.
- Diagnosed as recurrent implantation failure - at least two or more failure of achieving pregnancy following embryo transfer (ET) despite the optimum endometrial thickness and good quality of embryo (unexplained).
- Regular menstrual cycle atleast 3 months prior to treatment
- Not taking any hormonal treatment for atlest 3months prior to recruitment
Key exclusion criteria (5 listed)
- Concurrent significant pre-existing major medical conditions such as uncontrolled diabetes, active systemic lupus erythematosus (SLE) or Anti Phospholipid Syndrome (APS) that will interfere with implantation.
- Poor quality of embryo
- Suboptimal endometrial thickness(<8mm) during the embryo transfer (ET).
- On hormonal therapy prior to recruitment.
- Not agreed to participate
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 |
|---|---|---|
| GNRH Analoge, Duphaston, LetrozoleGNRH Analoge, Duphaston, Letrozole | Drug | Group A (GnRH analogue with Aromatase Inhibitor, Group B (GnRH analogue with Progesterone, Group C (GnRH analogue alone) |
Primary outcome
endometrial abv3-integrin expression expressions
Time frame: 12 months
pre and post treatment endometrial abv3-integrin expressions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Miscarriage, Recurrent
Not yet recruitingObservational study
Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes
Preeclampsia, Premature Birth
RecruitingPhase 2
Efficacy of Recombinant Human G-CSF in Women With Unexplained Recurrent Miscarriage
Recurrent Pregnancy Loss, Recurrent Miscarriages
RecruitingObservational study
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Infertility, Female, Miscarriage
Recruiting
Immune Profile Analysis and Biomarker Identification in Women With Repeated Implantation Failure or Unexplained Recurrent Spontaneous Miscarriage
Repeated Embryo Implantation Failure, Recurrent Miscarriage
RecruitingObservational study
Immune Cell Populations in the Endometrium
Infertility, Female, Recurrent Miscarriage
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GNRH Analoge, Duphaston, Letrozole in people with Miscarriage, Recurrent, run by Universiti Kebangsaan Malaysia Medical Centre 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?
The sponsor lists 6 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jun 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 abv3-integrin expression expressions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.