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Tubal PregnancyPhase 4NCT00137982

Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility

A Phase 4 study testing Treatment of ectopic pregnancy in people with Tubal Pregnancy, run by Hopital Antoine Beclere at 18 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. Read more about this study

Who is it for?
Ages 18 to 44 years, women only
Conditions the study is for
Tubal Pregnancy
What is being tested?
Treatment of ectopic pregnancy
Type of treatment
Surgery or procedure
How many people
600 participants
Where
18 sitesFrance
Study dates
Aug 2004to Jul 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis by ultra sound of ectopic pregnancy (EP)
  • Patients aged > 18 years old
  • Desire of future pregnancy

Who cannot join

  • EP by failure of contraception
  • EP associated with in vitro fertilization (IVF)

Trial locations and contacts

18 sites in 1 country.

Fernandez Hervé, PhD MD contact

+33 1 45 37 44 69

herve.fernandez@abc.aphp.fr

18 sites in 1 country

France18 sites, 18 recruiting

  • Angers Hospital

    Angers, 49033

    CATALA Laurent, MD, +33 2 41 35 46 35, lacatala@chu-angers.fr

    CATALA Laurent, MD

    Recruiting

  • Antoine Beclere Hospital

    Clamart, 92140

    DARRÉ Caroline, +33 1 45 37 45 59, caroline.darre@abc.aphp.fr

    FERNANDEZ Hervé, PhD, MD

    Recruiting

  • Créteil Hospital

    Créteil, 94000

    UZAN Catherine, MD, +33 6 03 57 86 35, catherine.uzan1@libertysurf.fr

    LÉONARD Franck, MD

    Recruiting

  • Franco-Britannique Hospital

    Levallois-Perret, 92300

    MAIROVITZ Valérie, MD, +33 1 46 39 22 97, vabomai@hotmail.com

    MAIROVITZ Valérie, MD

    Recruiting

  • Jeanne de Flandre Hospital

    Lille, 59037

    LUCOT Jean-Philippe, MD, +33 3 20 44 64 37, jplucot@chru-lille.fr

    LUCOT Jean-Philippe, MD

    Recruiting

  • Hôtel Dieu

    Lyon, 69288

    GOLFIER François, PhD, +33 4 72 41 32 44, francois.golfier@chu-lyon.fr

    GOLFIER François, PhD

    Recruiting

  • Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception

    Marseille, 13005

    AGOSTINI Aubert, MD, +33 6 10 56 80 52, aubert.agostini@mail.ap-hm.fr

    AGOSTINI Aubert, MD

    Recruiting

  • Assistance Publique Hôpitaux de Marseille ; Hôpital Nord

    Marseille, 13326

    BRETELLE Florence, PhD, MD, +33 4 91 96 46 72, florence.bretelle@mail-ap-hm.fr

    BRETELLE Florence, PhD, MD

    Recruiting

  • Maternité Régionale de Nancy

    Nancy, 54042

    DEVAL Bruno, PhD, MD, +33 83 34 44 52, b.deval@maternite.chu-nancy.fr

    ESZTO Marie-Laure, MD

    Recruiting

  • Nantes Hospital

    Nantes, 44093

    DARNIS Éric, MD, +33 2 40 08 32 24, eric.darnis@chu-nantes.fr

    DARNIS Éric, MD

    Recruiting

  • Lariboisière Hospital

    Paris, 75010

    FAZEL Afchine, MD, +33 1 49 95 85 42, afchine.fazel@lrb.aphp.fr

    FAZEL Afchine, MD

    Recruiting

  • Cochin Hospital

    Paris, 75679

    LEONARD Franck, MD, +33 1 58 41 18 81, franck.leonard@cch.aphp.fr

    CHOPIN Nicolas, MD

    Recruiting

  • Poissy Saint-Germain-en-Laye Hospital

    Poissy, 78303

    BELOT Franck, MD, +33 6 67 28 61 15, af.belot@gmail.com

    BELOT Franck, MD

    Recruiting

  • Roubaix Hospital

    Roubaix, 59100

    LE GOUEFF Françoise, MD, +33 3 20 99 32 50, francoise.le-goueff@ch-roubaix.fr

    LE GOUEFF Francoise, MD

    Recruiting

  • Charles Nicolle Hospital

    Rouen, 76031

    RESCH Benoît, MD, +33 2 32 88 89 90, benoit.resch@chu-rouen.fr

    RESCH Benoît, MD

    Recruiting

  • CMCO

    Schiltigheim, 67303

    VAYSSIERE Christophe, MD, +33 3 88 62 83 00, cvayssiere@club-internet.fr

    THOMA Véronique, MD

    Recruiting

  • Tours Hospital

    Tours, 37000

    MARRET Henri, PhD, +33 2 47 47 82 59, marret@med.univ-tours.fr

    MARRET Henri, Ph D

    Not yet recruiting

  • Versailles Hospital ; Hôpital André Mignot

    Versailles, 78157

    PANEL Pierre, MD, +33 1 39 63 97 33, ppanel@ch-versailles.fr

    RAYNAL Pierre, MD

    Recruiting

Other trials in France

About this study

Official title: Prospective Study, Randomized Controlled Trial Between Medical Treatment by Methotrexate Versus Conservative Surgical Treatment (Group 1) and Conservative Versus Radical Surgical Treatment (Group 2) to Evaluate Subsequent Fertility

Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. The investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.

Read the detailed description

The first group includes non active ectopic pregnancies defined by score or algorithm. In this case, we propose a randomized controlled trial between medical and conservative surgery. In all others clinical situations, we proposed surgery treatment. In a randomized controlled trial we compare conservative versus radical treatment. The patients are followed-up during 2 years with phone contact every 6 months.

Conditions
Tubal Pregnancy
Being tested
Treatment of ectopic pregnancy
Keywords
Ectopic pregnancy, Surgical treatment, Medical treatment, Fertility
Medical subject headings
Pregnancy, Tubal, Pregnancy, Ectopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment of ectopic pregnancyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subsequent fertility with 2 years follow-up

Secondary outcomes (4)

  1. Complications of treatments

  2. Time of hospitalisation

  3. Decrease curve of beta-hCG after treatment

  4. Success rate in each group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2005 (estimated)
  2. Study startAug 2004
  3. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00137982
Sponsor's protocol ID
P030409/AOR03040
Status last verified
Aug 2005
First submitted
29 Aug 2005
Last updated
8 Sep 2006
Results posted
No

Publications

  • Fernandez H, Gervaise A. Ectopic pregnancies after infertility treatment: modern diagnosis and therapeutic strategy. Hum Reprod Update. 2004 Nov-Dec;10(6):503-13. doi: 10.1093/humupd/dmh043. Epub 2004 Sep 23.

    PubMed 15388673

  • Bourel G, Pelletier-Fleury N, Bouyer J, Delbarre A, Fernandez H, Capmas P. Cost-effectiveness analysis of medical management versus conservative surgery for early tubal pregnancy. Hum Reprod. 2019 Feb 1;34(2):261-267. doi: 10.1093/humrep/dey352.

    PubMed 30520964

  • Fernandez H, Capmas P, Lucot JP, Resch B, Panel P, Bouyer J; GROG. Fertility after ectopic pregnancy: the DEMETER randomized trial. Hum Reprod. 2013 May;28(5):1247-53. doi: 10.1093/humrep/det037. Epub 2013 Mar 12.

    PubMed 23482340

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Treatment of ectopic pregnancy in people with Tubal Pregnancy, run by Hopital Antoine Beclere at 18 sites 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 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fernandez Hervé, PhD MD (+33 1 45 37 44 69, herve.fernandez@abc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subsequent fertility with 2 years follow-up. 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 NCT00137982, 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 8 Sep 2006.

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