Incomplete MiscarriageHY-PERNCT02201732
Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions
A study testing Hysteroscopy and Curettage in people with Incomplete Miscarriage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study of is to compare subsequent fertility rates between hysteroscopy and aspirative curettage in the surgical treatment of incomplete spontaneous abortion Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Incomplete Miscarriage
- What is being tested?
- Hysteroscopy and Curettage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2014to 3 Jul 2020
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Major, under 45 years with intrauterine trophoblastic retention after incomplete miscarriage in the first quarter (termination of pregnancy < 14 WA),
- With desire of pregnancy ;
- Intrauterine trophoblastic retention diagnosed by transvaginal pelvic ultrasound finding a intrauterine heterogeneous image or intrauterine gestational sac more than 15 mm in thickness, complicated or not of endometritis ;
- Decision to surgical management of incomplete miscarriage by the health care team ;
- Patient beneficiary or affiliated to a health insurance
- Informed and signed consent
Who cannot join
- Will not be included in the protocol patients :
- having a uterine malformation known ;
- having received surgical treatment for the current intrauterine retention ;
- with intrauterine retention diagnosed by transvaginal pelvic ultrasound of more than 50 mm in thickness ;
- requiring a haemostatic act in urgency for heavy vaginal bleeding (miscarriage haemorrhage) ;
- bearer of intrauterine device ;
Show all 10Show fewer
- having an evolutive pregnancy;
- having an ectopic pregnancy;
- having a trophoblastic retention following a voluntary abortion ;
- having a pregnancy achieved by medically assisted procreation
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier intercommunal de poissy-saint germain en Laye
Poissy, 78300
About this study
Official title: Assessment of the Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions
The purpose of this study of is to compare subsequent fertility rates between hysteroscopy and aspirative curettage in the surgical treatment of incomplete spontaneous abortion
Read the detailed description
Incomplete spontaneous abortion (ISA) is defined by the intrauterine retention of conceptual product after incomplete or partial expulsion of the conceptual product. Treatment such retention may be expectant care, medical treatment or surgery. Currently, curettage is the standard surgical treatment in most centers. However, operative hysteroscopy, in addition to the direct visualization of the retained conceptual product, in contrast to the curettage, would allow elective evacuation of retention while reducing surgical complications. Studies of low effective, retrospective, have found an fertility's increase in patients treated by operative hysteroscopy. These data need to be confirmed by a randomized controlled trial in order to change the standard surgical treatment of this disease if hysteroscopy procedure would found to be superior.
We propose a multicenter - single blind - randomized - therapeutic study. Randomization will concern the surgical procedure in patients treated surgically for intrauterine retention after spontaneous miscarriage. Randomization will be performed at the admission to the patient in the operating room by electronic means using a secure internet platform, single-blind for the patient with unblinding at the end of the trial or in case of complication. The patient will be randomly assigned to one of two treatment arms following:
- Arm A : Operative hysteroscopy
- Arm B : Aspirative curettage The inclusion will be performed at time of diagnosis (incomplete miscarriage) with an ultrasound of intrauterine retention for which surgical treatment has been decided. The initial medical examination (inclusion visit) will include a complete gynecological examination. The diagnosis of incomplete miscarriage will be performed using a transvaginal pelvic ultrasound. Transvaginal ultrasound will be performed according to a technique of standardized pelvic ultrasound ; the retention will be diagnosed in the presence of a heterogeneous image or intrauterine gestational sac more than 15 mm in thickness. On this visit, the patient will complete a questionnaire concerning her medical histories and the aborted pregnancy.
Patients will have a care in accordance with center practices for the hospital stay. Surgical treatment will be performed within the time depending on the availability of the operating room of participating center.
A hospitalization report indicating the participation to the study, but not mentioning the treatment group, will be sent to the attending physician and the patient. An information form with postoperative instructions will be given to patients included in this protocol without mentioning the surgical arm. The operative report will be given to the patient at the end of her participation in the trial.
A total of five visits (including final visit) are scheduled for this trial. The patient will be monitored in the form of telephone conversation or questionnaire sent by email or post. Monitoring will be done by the investigator that enrolled the patient with the help of the URC in charge of the project. In case of complications, failure of the intervention or diagnosis of a uterine cavity pathology, the care will be left to the discretion of the medical center team.
- Conditions
- Incomplete Miscarriage
- Being tested
- Hysteroscopy, Curettage
- Keywords
- Incomplete miscarriage, Hysteroscopy, curettage, pregnancy, RCT
- Medical subject headings
- Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyProcedure or surgery
Performed under general or local anesthesia, antibioprophylaxis in accordance to center practices may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.
CurettageProcedure or surgery
Performed under general or local anesthesia, the used material may be rigid or flexible vacurette. In the same way, the prophylactic antibiotic, the diameter of the used vacurette, the importance of cervical dilation necessary and a possible peroperative ultrasound guidance will be left at the discretion of the operator and habits of the center. A check of the uterine vacuity by foam curette will be conducted at the end of curettage.
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Operative hysteroscopy | Experimental | operative hysteroscopy with direct visualization Receives: Procedure: Hysteroscopy |
| Arm B : Aspirative curettage | Active comparator | curettage is the standard surgical treatment in most centers Receives: Procedure: Curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive intrauterine pregnancy > 22 WA
Questionnaire
Measured: Until 2 years post surgery
Secondary outcomes (3)
Next pregnancy
Measured: Until 2 years post surgery
Surgical complications' rate
Clavien-Dindo classification
Measured: until 2 years post surgery
Surgical reinterventions
Measured: until 2 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study start5 Nov 2014
- Primary completion15 Nov 2019
- Study completion3 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Incomplete MiscarriageStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Arnaud FAUCONNIER, MD, PhD, Study director, Centre Hospitalier Intercommunal de Poissy / Saint-Germain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201732
- Sponsor's protocol ID
- P130920
- Other IDs
- 2014-A00340-47
- Acronym
- HY-PER
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2014
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Huchon C, Drioueche H, Koskas M, Agostini A, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Panel P, Raiffort C, Giraudet G, Bussieres L, Fauconnier A. Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial. JAMA. 2023 Apr 11;329(14):1197-1205. doi: 10.1001/jama.2023.3415.
PubMed 37039805Huchon C, Koskas M, Agostini A, Akladios C, Alouini S, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Matheron I, Panel P, Raiffort C, Fauconnier A. Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial. Trials. 2015 Aug 19;16:363. doi: 10.1186/s13063-015-0900-1.
PubMed 26282937Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PubMed 34061352
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions
- ClinicalTrials.gov ID
- NCT02201732
- Acronym / sponsor ID
- HY-PER / P130920
- Conditions
- Incomplete Miscarriage
- Keywords
- Incomplete miscarriage, Hysteroscopy, curettage, pregnancy, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 28 Jul 2014 (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.
The purpose of this study of is to compare subsequent fertility rates between hysteroscopy and aspirative curettage in the surgical treatment of incomplete spontaneous abortion
Detailed description
Incomplete spontaneous abortion (ISA) is defined by the intrauterine retention of conceptual product after incomplete or partial expulsion of the conceptual product. Treatment such retention may be expectant care, medical treatment or surgery. Currently, curettage is the standard surgical treatment in most centers. However, operative hysteroscopy, in addition to the direct visualization of the retained conceptual product, in contrast to the curettage, would allow elective evacuation of retention while reducing surgical complications. Studies of low effective, retrospective, have found an fertility's increase in patients treated by operative hysteroscopy. These data need to be confirmed by a randomized controlled trial in order to change the standard surgical treatment of this disease if hysteroscopy procedure would found to be superior.
We propose a multicenter - single blind - randomized - therapeutic study. Randomization will concern the surgical procedure in patients treated surgically for intrauterine retention after spontaneous miscarriage. Randomization will be performed at the admission to the patient in the operating room by electronic means using a secure internet platform, single-blind for the patient with unblinding at the end of the trial or in case of complication. The patient will be randomly assigned to one of two treatment arms following:
- Arm A : Operative hysteroscopy
- Arm B : Aspirative curettage The inclusion will be performed at time of diagnosis (incomplete miscarriage) with an ultrasound of intrauterine retention for which surgical treatment has been decided. The initial medical examination (inclusion visit) will include a complete gynecological examination. The diagnosis of incomplete miscarriage will be performed using a transvaginal pelvic ultrasound. Transvaginal ultrasound will be performed according to a technique of standardized pelvic ultrasound ; the retention will be diagnosed in the presence of a heterogeneous image or intrauterine gestational sac more than 15 mm in thickness. On this visit, the patient will complete a questionnaire concerning her medical histories and the aborted pregnancy.
Patients will have a care in accordance with center practices for the hospital stay. Surgical treatment will be performed within the time depending on the availability of the operating room of participating center.
A hospitalization report indicating the participation to the study, but not mentioning the treatment group, will be sent to the attending physician and the patient. An information form with postoperative instructions will be given to patients included in this protocol without mentioning the surgical arm. The operative report will be given to the patient at the end of her participation in the trial.
A total of five visits (including final visit) are scheduled for this trial. The patient will be monitored in the form of telephone conversation or questionnaire sent by email or post. Monitoring will be done by the investigator that enrolled the patient with the help of the URC in charge of the project. In case of complications, failure of the intervention or diagnosis of a uterine cavity pathology, the care will be left to the discretion of the medical center team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : Operative hysteroscopy | Experimental | Procedure: Hysteroscopyoperative hysteroscopy with direct visualization |
| Arm B : Aspirative curettage | Active comparator | Procedure: Curettagecurettage is the standard surgical treatment in most centers |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Major, under 45 years with intrauterine trophoblastic retention after incomplete miscarriage in the first quarter (termination of pregnancy < 14 WA),
- With desire of pregnancy ;
- Intrauterine trophoblastic retention diagnosed by transvaginal pelvic ultrasound finding a intrauterine heterogeneous image or intrauterine gestational sac more than 15 mm in thickness, complicated or not of endometritis ;
- Decision to surgical management of incomplete miscarriage by the health care team ;
- Patient beneficiary or affiliated to a health insurance
Key exclusion criteria (10 listed)
- having a uterine malformation known ;
- having received surgical treatment for the current intrauterine retention ;
- with intrauterine retention diagnosed by transvaginal pelvic ultrasound of more than 50 mm in thickness ;
- requiring a haemostatic act in urgency for heavy vaginal bleeding (miscarriage haemorrhage) ;
- bearer of intrauterine device ;
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 |
|---|---|---|
| HysteroscopyPerformed under general or local anesthesia, antibioprophylaxis in accordance to center practices may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg. | Procedure or surgery | Arm A : Operative hysteroscopy |
| CurettagePerformed under general or local anesthesia, the used material may be rigid or flexible vacurette. In the same way, the prophylactic antibiotic, the diameter of the used vacurette, the importance of cervical dilation necessary and a possible peroperative ultrasound guidance will be left at the discretion of the operator and habits of the center. A check of the uterine vacuity by foam curette will be conducted at the end of curettage. | Procedure or surgery | Arm B : Aspirative curettage |
Primary outcome
Progressive intrauterine pregnancy > 22 WA
Time frame: Until 2 years post surgery
Questionnaire
3 secondary outcomes
Next pregnancy
Time frame: Until 2 years post surgery
Surgical complications' rate
Time frame: until 2 years post surgery
Surgical reinterventions
Time frame: until 2 years post surgery
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 5 Sep 2025.
- Results publication: PubMed 37039805Huchon C, Drioueche H, Koskas M, Agostini A, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Panel P, Raiffort C, Giraudet G, Bussieres L, Fauconnier A. Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial. JAMA. 2023 Apr 11;329(14):1197-1205. doi: 10.1001/jama.2023.3415.
- Results publication: PubMed 26282937Huchon C, Koskas M, Agostini A, Akladios C, Alouini S, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Matheron I, Panel P, Raiffort C, Fauconnier A. Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial. Trials. 2015 Aug 19;16:363. doi: 10.1186/s13063-015-0900-1.
- Derived from this study: PubMed 34061352Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
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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.
Arnaud FAUCONNIER, MD, PhD study director
Centre Hospitalier Intercommunal de Poissy / Saint-Germain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy and Curettage in people with Incomplete Miscarriage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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: finished, as of the sponsor's last update on 5 Sep 2025. 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 France. 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?
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?
Progressive intrauterine pregnancy > 22 WA (time frame: Until 2 years post surgery). 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 NCT02201732, which also lists 3 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 5 Sep 2025.