Pregnancy LossPhase 3PREMISENCT07796737
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
A Phase 3 study testing Vaginal Micronized Progesterone (Progesterone Besins) and Enoxaparin (Clexane) in people with Pregnancy Loss and Pregnancy Loss, Early, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
This prospective, single-centre, open-label, randomized Phase III superiority trial will enroll approximately 268 women aged 18-40 years with at least two consecutive unexplained miscarriages and a singleton intrauterine pregnancy confirmed by ultrasound at 5-7 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy Loss, Pregnancy Loss, Early
- What is being tested?
- Vaginal Micronized Progesterone (Progesterone Besins) and Enoxaparin (Clexane)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2026to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40 years.
- History of at least two consecutive unexplained miscarriages.
- Confirmed pregnancy at 5-7 weeks of gestation, with a singleton intrauterine pregnancy confirmed by ultrasound before randomization.
- Willingness to comply with study procedures and, if assigned to the intervention arm, to use vaginal progesterone and administer daily subcutaneous enoxaparin injections; ability to provide written informed consent.
- No medical contraindication to progesterone or low-molecular-weight heparin.
Who cannot join
- Documented antiphospholipid syndrome or any current anticoagulant requirement.
- Clinically significant thyroid disease requiring treatment adjustment.
- Anatomical abnormalities (such as significant uterine malformations or large fibroids) conclusively linked to recurrent pregnancy loss.
- Known hypersensitivity to enoxaparin or heparins, or prior heparin-induced thrombocytopenia.
- Use of systemic steroids beyond standard pregnancy doses for other immunological or inflammatory conditions.
- Severe renal insufficiency (estimated glomerular filtration rate below 30 mL/min), advanced liver disease, or other clinically significant systemic autoimmune disease (such as systemic lupus erythematosus or rheumatoid arthritis) that may affect pregnancy or study compliance.
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- Inability or unwillingness to comply with study requirements (for example, language barriers or severe psychiatric conditions).
- Known parental chromosomal abnormalities.
- Multiple pregnancy.
- Current use of progesterone or other progestogen therapy for luteal support at screening or randomization, including luteal support after assisted reproductive technology, such as in vitro fertilization or frozen embryo transfer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
General University Hospital in Prague
Prague, 12800
Zdeněk Laštůvka, MD, PhD, +420 224 76 7577, zdenek.lastuvka@vfn.cz
About this study
Official title: Randomized Open-Label Controlled Trial Evaluating the Efficacy of the Combination of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
This prospective, single-centre, open-label, randomized Phase III superiority trial will enroll approximately 268 women aged 18-40 years with at least two consecutive unexplained miscarriages and a singleton intrauterine pregnancy confirmed by ultrasound at 5-7 weeks of gestation. Participants will be randomly assigned in a 1:1 ratio to standard antenatal care without active pharmacological treatment for recurrent pregnancy loss or to vaginal micronized progesterone plus subcutaneous enoxaparin. The primary outcome is live birth at or beyond 24+0 weeks of gestation. Study follow-up continues through six weeks postpartum. Delivery and postpartum outcomes will be obtained remotely using a structured participant-completed questionnaire. An optional exploratory translational sub-study involving one maternal blood sample at 10-12 weeks requires separate informed consent.
Read the detailed description
Participants will be randomized centrally using a computer-generated sequence with randomly varying block sizes and an electronic allocation system. In the intervention arm, vaginal micronized progesterone will be given at 400 mg twice daily through 16+0 weeks of gestation and 200 mg once daily at night from 16+1 through 36+0 weeks. Enoxaparin will be administered subcutaneously once daily at 40 mg for participants weighing less than 100 kg and 60 mg for participants weighing 100 kg or more, based on body weight at randomization, until 36+0 weeks. The control arm will receive routine antenatal care without study pharmacological treatment. Protocol-specific assessments will be coordinated by the single trial site and, where feasible, embedded in routine antenatal visits; no additional routine study visits are required. Intervention-arm participants will undergo safety monitoring including platelet count and renal function assessments. Maternal and neonatal outcomes will be collected by participant-completed questionnaire following delivery and at six weeks postpartum. Participants will remain under follow-up regardless of pregnancy outcome. Optional exploratory immunological analyses in maternal blood at 10-12 weeks will be conducted only after separate informed consent; optional biobanking likewise requires appropriate separate consent. External health-care providers may refer patients, but will not conduct trial-specific procedures.
- Conditions
- Pregnancy Loss, Pregnancy Loss, Early
- Being tested
- Vaginal Micronized Progesterone (Progesterone Besins), Enoxaparin (Clexane)
- Keywords
- progesterone, low molecular weight heparine, recurrent miscarriage, pregnancy loss
- Medical subject headings
- Abortion, Spontaneous, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Micronized Progesterone (Progesterone Besins)Drug
Vaginal micronized progesterone 400 mg twice daily (total 800 mg/day) from treatment initiation at 5-7 weeks through 16+0 weeks of gestation, followed by 200 mg vaginally once daily at night from 16+1 through 36+0 weeks of gestation. Treatment may be interrupted or discontinued for protocol-specified safety reasons
Enoxaparin (Clexane)Drug
Subcutaneous enoxaparin once daily, at a prophylactic dose based on maternal body weight at randomization: 4,000 anti-Xa IU (40 mg) for participants weighing less than 100 kg, or 6,000 anti-Xa IU (60 mg) for participants weighing 100 kg or more. Treatment starts at 5-7 weeks following pregnancy confirmation and continues through 36+0 weeks of gestation unless medically discontinued earlier. If delivery occurs before 36+0 weeks, treatment stops at the onset of labour.
| Study group | Role | What they receive |
|---|---|---|
| ARM A | No intervention | Participants receive routine antenatal care according to local Czech clinical practice. No investigational medicinal product or active pharmacological treatment for recurrent pregnancy loss is administered in this arm. Folic acid or standard prenatal vitamins are recommended. Concomitant medication is recorded. |
| ARM B | Experimental | Participants receive vaginal micronized progesterone and daily subcutaneous enoxaparin from 5-7 weeks of gestation following confirmation of intrauterine pregnancy, with treatment continued as specified below through 36+0 weeks unless earlier discontinuation is clinically indicated or delivery occurs. Receives: Drug: Vaginal Micronized Progesterone (Progesterone Besins); Drug: Enoxaparin (Clexane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate
Proportion of randomized participants who deliver at least one live-born infant at 24+0 weeks of gestation or later. Live birth status and gestational age at delivery will be ascertained using the structured participant-completed postpartum questionnaire.
Measured: At delivery (≥24+0 weeks of gestation)
Secondary outcomes (7)
Ongoing Pregnancy Rate at 22 Weeks
Proportion of randomized participants with an ongoing intrauterine pregnancy at 22+0 weeks of gestation, based on participant-reported information.
Measured: From enrollment to the end of 22 weeks of the index pregnancy.
Maternal Complications
Incidence of pregnancy-related complications, including preeclampsia (defined by ISSHP), gestational hypertension, gestational diabetes, placental abruption, postpartum hemorrhage (defined as estimated blood loss >500 mL following vaginal delivery or >1000 mL following cesarean section).
Measured: From enrollment to the end of treatment at 6 weeks post-labor.
Neonatal Outcomes:
Birth weight (grams), APGAR scores at 1 and 5 minutes post-delivery (APGAR at 10 minutes may be recorded if available), admission to neonatal care unit (NICU), and presence of congenital anomalies confirmed postnatally. According to participant-reported records.
Measured: From enrollment to the end of treatment at 6 weeks post-labor.
Safety of the trial medication
Incidence of major bleeding events (overt bleeding requiring transfusion, surgical intervention, or hemodynamic intervention) and minor bleeding events (mucosal or injection-site bleeding), thrombocytopenia (defined as platelet count <100,000/μL), hypersensivity, and injection-site reactions.
Measured: From enrollment to the end of treatment at 6 weeks post-labor.
Adherence and Tolerability:
Treatment discontinuation rate and reasons for discontinuation (including adverse events); participant-reported injection-site pain associated with LMWH treatment, assessed using a numerical rating scale from 0 (no pain) to 10 (worst imaginable pain); participant-reported missed doses of study treatment and reasons for missed doses; and completeness of medication diaries.
Measured: Treatment discontinuation: from initiation at 5-7 weeks' gestation to 36+0 weeks or delivery. Pain and missed-dose outcomes: assessed at 20 and 34 weeks' gestation and 6 weeks postpartum.
Incidence of Fetal Growth Restriction
Proportion of pregnancies with fetal growth restriction as reported during antenatal care.
Measured: From enrollment to the end of treatment at 6 weeks post-labor.
Gestational Age at Delivery
Gestational age at delivery, expressed in completed weeks and days, ascertained from the structured participant-completed postpartum questionnaire.
Measured: From enrollment to the end of treatment at 6 weeks post-labor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pregnancy LossStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zdenek Lastuvka, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796737
- Sponsor's protocol ID
- PREMISE-01
- Other IDs
- 2026-528492-40-00
- Acronym
- PREMISE
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: GDPR requirements
Publications
Clark P, Walker ID, Langhorne P, Crichton L, Thomson A, Greaves M, Whyte S, Greer IA; Scottish Pregnancy Intervention Study (SPIN) collaborators. SPIN (Scottish Pregnancy Intervention) study: a multicenter, randomized controlled trial of low-molecular-weight heparin and low-dose aspirin in women with recurrent miscarriage. Blood. 2010 May 27;115(21):4162-7. doi: 10.1182/blood-2010-01-267252. Epub 2010 Mar 17.
PubMed 20237316Gris JC, Mercier E, Quere I, Lavigne-Lissalde G, Cochery-Nouvellon E, Hoffet M, Ripart-Neveu S, Tailland ML, Dauzat M, Mares P. Low-molecular-weight heparin versus low-dose aspirin in women with one fetal loss and a constitutional thrombophilic disorder. Blood. 2004 May 15;103(10):3695-9. doi: 10.1182/blood-2003-12-4250. Epub 2004 Jan 22.
PubMed 14739212Coomarasamy A, Williams H, Truchanowicz E, Seed PT, Small R, Quenby S, Gupta P, Dawood F, Koot YE, Bender Atik R, Bloemenkamp KW, Brady R, Briley AL, Cavallaro R, Cheong YC, Chu JJ, Eapen A, Ewies A, Hoek A, Kaaijk EM, Koks CA, Li TC, MacLean M, Mol BW, Moore J, Ross JA, Sharpe L, Stewart J, Vaithilingam N, Farquharson RG, Kilby MD, Khalaf Y, Goddijn M, Regan L, Rai R. A Randomized Trial of Progesterone in Women with Recurrent Miscarriages. N Engl J Med. 2015 Nov 26;373(22):2141-8. doi: 10.1056/NEJMoa1504927.
PubMed 26605928Ectopic pregnancy and miscarriage: diagnosis and initial management. London: National Institute for Health and Care Excellence (NICE); 2023 Aug 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK544906/
PubMed 31393678Coomarasamy A, Devall AJ, Cheed V, Harb H, Middleton LJ, Gallos ID, Williams H, Eapen AK, Roberts T, Ogwulu CC, Goranitis I, Daniels JP, Ahmed A, Bender-Atik R, Bhatia K, Bottomley C, Brewin J, Choudhary M, Crosfill F, Deb S, Duncan WC, Ewer A, Hinshaw K, Holland T, Izzat F, Johns J, Kriedt K, Lumsden MA, Manda P, Norman JE, Nunes N, Overton CE, Quenby S, Rao S, Ross J, Shahid A, Underwood M, Vaithilingam N, Watkins L, Wykes C, Horne A, Jurkovic D. A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. N Engl J Med. 2019 May 9;380(19):1815-1824. doi: 10.1056/NEJMoa1813730.
PubMed 31067371Christiansen OB, Nybo Andersen AM, Bosch E, Daya S, Delves PJ, Hviid TV, Kutteh WH, Laird SM, Li TC, van der Ven K. Evidence-based investigations and treatments of recurrent pregnancy loss. Fertil Steril. 2005 Apr;83(4):821-39. doi: 10.1016/j.fertnstert.2004.12.018.
PubMed 15820784ESHRE Guideline Group on RPL; Bender Atik R, Christiansen OB, Elson J, Kolte AM, Lewis S, Middeldorp S, Mcheik S, Peramo B, Quenby S, Nielsen HS, van der Hoorn ML, Vermeulen N, Goddijn M. ESHRE guideline: recurrent pregnancy loss: an update in 2022. Hum Reprod Open. 2023 Mar 2;2023(1):hoad002. doi: 10.1093/hropen/hoad002. eCollection 2023.
PubMed 36873081
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-Label Controlled Trial Evaluating the Efficacy of the Combination of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT07796737
- Acronym / sponsor ID
- PREMISE / PREMISE-01
- Conditions
- Pregnancy Loss, Pregnancy Loss, Early
- Keywords
- progesterone, low molecular weight heparine, recurrent miscarriage, pregnancy loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Sep 2026 (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.
This prospective, single-centre, open-label, randomized Phase III superiority trial will enroll approximately 268 women aged 18-40 years with at least two consecutive unexplained miscarriages and a singleton intrauterine pregnancy confirmed by ultrasound at 5-7 weeks of gestation. Participants will be randomly assigned in a 1:1 ratio to standard antenatal care without active pharmacological treatment for recurrent pregnancy loss or to vaginal micronized progesterone plus subcutaneous enoxaparin. The primary outcome is live birth at or beyond 24+0 weeks of gestation. Study follow-up continues through six weeks postpartum. Delivery and postpartum outcomes will be obtained remotely using a structured participant-completed questionnaire. An optional exploratory translational sub-study involving one maternal blood sample at 10-12 weeks requires separate informed consent.
Detailed description
Participants will be randomized centrally using a computer-generated sequence with randomly varying block sizes and an electronic allocation system. In the intervention arm, vaginal micronized progesterone will be given at 400 mg twice daily through 16+0 weeks of gestation and 200 mg once daily at night from 16+1 through 36+0 weeks. Enoxaparin will be administered subcutaneously once daily at 40 mg for participants weighing less than 100 kg and 60 mg for participants weighing 100 kg or more, based on body weight at randomization, until 36+0 weeks. The control arm will receive routine antenatal care without study pharmacological treatment. Protocol-specific assessments will be coordinated by the single trial site and, where feasible, embedded in routine antenatal visits; no additional routine study visits are required. Intervention-arm participants will undergo safety monitoring including platelet count and renal function assessments. Maternal and neonatal outcomes will be collected by participant-completed questionnaire following delivery and at six weeks postpartum. Participants will remain under follow-up regardless of pregnancy outcome. Optional exploratory immunological analyses in maternal blood at 10-12 weeks will be conducted only after separate informed consent; optional biobanking likewise requires appropriate separate consent. External health-care providers may refer patients, but will not conduct trial-specific procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | No intervention | –Participants receive routine antenatal care according to local Czech clinical practice. No investigational medicinal product or active pharmacological treatment for recurrent pregnancy loss is administered in this arm. Folic acid or standard prenatal vitamins are recommended. Concomitant medication is recorded. |
| ARM B | Experimental | Drug: Vaginal Micronized Progesterone (Progesterone Besins), Drug: Enoxaparin (Clexane)Participants receive vaginal micronized progesterone and daily subcutaneous enoxaparin from 5-7 weeks of gestation following confirmation of intrauterine pregnancy, with treatment continued as specified below through 36+0 weeks unless earlier discontinuation is clinically indicated or delivery occurs. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-40 years.
- History of at least two consecutive unexplained miscarriages.
- Confirmed pregnancy at 5-7 weeks of gestation, with a singleton intrauterine pregnancy confirmed by ultrasound before randomization.
- Willingness to comply with study procedures and, if assigned to the intervention arm, to use vaginal progesterone and administer daily subcutaneous enoxaparin injections; ability to provide written informed consent.
- No medical contraindication to progesterone or low-molecular-weight heparin.
Key exclusion criteria (10 listed)
- Documented antiphospholipid syndrome or any current anticoagulant requirement.
- Clinically significant thyroid disease requiring treatment adjustment.
- Anatomical abnormalities (such as significant uterine malformations or large fibroids) conclusively linked to recurrent pregnancy loss.
- Known hypersensitivity to enoxaparin or heparins, or prior heparin-induced thrombocytopenia.
- Use of systemic steroids beyond standard pregnancy doses for other immunological or inflammatory conditions.
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 |
|---|---|---|
| Vaginal Micronized Progesterone (Progesterone Besins)Vaginal micronized progesterone 400 mg twice daily (total 800 mg/day) from treatment initiation at 5-7 weeks through 16+0 weeks of gestation, followed by 200 mg vaginally once daily at night from 16+1 through 36+0 weeks of gestation. Treatment may be interrupted or discontinued for protocol-specified safety reasons | Drug | ARM B |
| Enoxaparin (Clexane)Subcutaneous enoxaparin once daily, at a prophylactic dose based on maternal body weight at randomization: 4,000 anti-Xa IU (40 mg) for participants weighing less than 100 kg, or 6,000 anti-Xa IU (60 mg) for participants weighing 100 kg or more. Treatment starts at 5-7 weeks following pregnancy confirmation and continues through 36+0 weeks of gestation unless medically discontinued earlier. If delivery occurs before 36+0 weeks, treatment stops at the onset of labour. | Drug | ARM B |
Primary outcome
Live Birth Rate
Time frame: At delivery (≥24+0 weeks of gestation)
Proportion of randomized participants who deliver at least one live-born infant at 24+0 weeks of gestation or later. Live birth status and gestational age at delivery will be ascertained using the structured participant-completed postpartum questionnaire.
7 secondary outcomes
Ongoing Pregnancy Rate at 22 Weeks
Time frame: From enrollment to the end of 22 weeks of the index pregnancy.
Maternal Complications
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Neonatal Outcomes:
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Safety of the trial medication
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Adherence and Tolerability:
Time frame: Treatment discontinuation: from initiation at 5-7 weeks' gestation to 36+0 weeks or delivery. Pain and missed-dose outcomes: assessed at 20 and 34 weeks' gestation and 6 weeks postpartum.
Incidence of Fetal Growth Restriction
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Gestational Age at Delivery
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 20237316Clark P, Walker ID, Langhorne P, Crichton L, Thomson A, Greaves M, Whyte S, Greer IA; Scottish Pregnancy Intervention Study (SPIN) collaborators. SPIN (Scottish Pregnancy Intervention) study: a multicenter, randomized controlled trial of low-molecular-weight heparin and low-dose aspirin in women with recurrent miscarriage. Blood. 2010 May 27;115(21):4162-7. doi: 10.1182/blood-2010-01-267252. Epub 2010 Mar 17.
- Background: PubMed 14739212Gris JC, Mercier E, Quere I, Lavigne-Lissalde G, Cochery-Nouvellon E, Hoffet M, Ripart-Neveu S, Tailland ML, Dauzat M, Mares P. Low-molecular-weight heparin versus low-dose aspirin in women with one fetal loss and a constitutional thrombophilic disorder. Blood. 2004 May 15;103(10):3695-9. doi: 10.1182/blood-2003-12-4250. Epub 2004 Jan 22.
- Background: PubMed 26605928Coomarasamy A, Williams H, Truchanowicz E, Seed PT, Small R, Quenby S, Gupta P, Dawood F, Koot YE, Bender Atik R, Bloemenkamp KW, Brady R, Briley AL, Cavallaro R, Cheong YC, Chu JJ, Eapen A, Ewies A, Hoek A, Kaaijk EM, Koks CA, Li TC, MacLean M, Mol BW, Moore J, Ross JA, Sharpe L, Stewart J, Vaithilingam N, Farquharson RG, Kilby MD, Khalaf Y, Goddijn M, Regan L, Rai R. A Randomized Trial of Progesterone in Women with Recurrent Miscarriages. N Engl J Med. 2015 Nov 26;373(22):2141-8. doi: 10.1056/NEJMoa1504927.
- Background: PubMed 31393678Ectopic pregnancy and miscarriage: diagnosis and initial management. London: National Institute for Health and Care Excellence (NICE); 2023 Aug 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK544906/
- Background: PubMed 31067371Coomarasamy A, Devall AJ, Cheed V, Harb H, Middleton LJ, Gallos ID, Williams H, Eapen AK, Roberts T, Ogwulu CC, Goranitis I, Daniels JP, Ahmed A, Bender-Atik R, Bhatia K, Bottomley C, Brewin J, Choudhary M, Crosfill F, Deb S, Duncan WC, Ewer A, Hinshaw K, Holland T, Izzat F, Johns J, Kriedt K, Lumsden MA, Manda P, Norman JE, Nunes N, Overton CE, Quenby S, Rao S, Ross J, Shahid A, Underwood M, Vaithilingam N, Watkins L, Wykes C, Horne A, Jurkovic D. A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. N Engl J Med. 2019 May 9;380(19):1815-1824. doi: 10.1056/NEJMoa1813730.
- Background: PubMed 15820784Christiansen OB, Nybo Andersen AM, Bosch E, Daya S, Delves PJ, Hviid TV, Kutteh WH, Laird SM, Li TC, van der Ven K. Evidence-based investigations and treatments of recurrent pregnancy loss. Fertil Steril. 2005 Apr;83(4):821-39. doi: 10.1016/j.fertnstert.2004.12.018.
- Background: PubMed 36873081ESHRE Guideline Group on RPL; Bender Atik R, Christiansen OB, Elson J, Kolte AM, Lewis S, Middeldorp S, Mcheik S, Peramo B, Quenby S, Nielsen HS, van der Hoorn ML, Vermeulen N, Goddijn M. ESHRE guideline: recurrent pregnancy loss: an update in 2022. Hum Reprod Open. 2023 Mar 2;2023(1):hoad002. doi: 10.1093/hropen/hoad002. eCollection 2023.
- Individual participant dataSharing planned: No. GDPR requirements
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaginal Micronized Progesterone (Progesterone Besins) and Enoxaparin (Clexane) in people with Pregnancy Loss and Pregnancy Loss, Early, run by General University Hospital, Prague at 1 site in Czechia.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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 Czechia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zdeněk Laštůvka, MD, PhD (+420 224767577, zdenek.lastuvka@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth Rate (time frame: At delivery (≥24+0 weeks of gestation)). 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 NCT07796737, which also lists 7 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 28 Oct 2026.