In Vitro FertilizationPhase 3NCT00828191

Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)

A Phase 3 study testing Progesterone in people with In Vitro Fertilization, run by IBSA Institut Biochimique SA at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg… Read more about this study

Who is it for?: Ages 18 to 42 years, women only
Conditions the study is for: In Vitro Fertilization
What is being tested?: Progesterone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 800 participants
Where: 8 sitesUnited States
Study dates: Dec 2008to Feb 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 42 years
Women only
No healthy volunteers
Adult

Who may be able to join

Patient has given written informed consent;
BMI < 30 kg/m2;
Age 18 - 42 (upon starting COH);
<3 prior ART cycles (IVF, ICSI and related procedures);
Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyps or protruding submucosal fibroids);
Patients must have at least three retrieved oocytes.

Who cannot join

Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
Stage III or IV endometriosis (no endometriomas);
Hydrosalpinges;
History of past poor response to COH resulting in canceling ART;
Use of thawed/donated oocytes;
Use of thawed/donated embryos;

Show all 21Show fewer

Gestational carrier;
Patients affected by pathologies associated with any contraindication of being pregnant;
Hypersensitivity to study medication;
Uncontrolled adrenal or thyroid dysfunction;
History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
History of arterial disease;
Patients with hepatic impairment (liver function tests > 2x upper limits of normal);
Patients with dermatologic disease;
Patients with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2);
Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
High grade cervical dysplasia;
History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages, wherein pregnancy developed to a minimum of a gestational sac on TVUS;
Participation in a concurrent clinical trial or in another trial within the past 2 months;
Use of concomitant medications that might interfere with the study evaluation;
Pre-implantation genetic diagnosis/screening

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Center for Assisted Reproduction
Bedford, Texas, 76022
Idaho Center for Reproductive Medicine
Boise, Idaho, 83702
Center for Reproductive Medicine
Orlando, Florida, 32804
Reproductive Partners Medical Group, Inc.
Redondo Beach, California, 90277
Fertility Physicians of Northern California
San Jose, California, 95124
Seattle Reproductive Medicine
Seattle, Washington, 98109
Stanford University Medical Center
Stanford, California, 94305
Fertility and Surgical Associates of California
Thousand Oaks, California, 91360

Other trials in United States

About this study

Official title: Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)

Conditions: In Vitro Fertilization
Being tested: Progesterone
Keywords: Luteal support in IVF

What participants receive

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

ProgesteroneDrug
25 mg, once a day, SC
ProgesteroneDrug
100 mg, twice a day, vaginally

Study groups in NCT00828191
Study group	Role	What they receive
Progesterone SC	Experimental	Not described Receives: Drug: Progesterone
Progesterone Tablets	Active comparator	Not described Receives: Drug: Progesterone

What is being measured

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

Ongoing Pregnancy Rate
Measured: 10 weeks after treatment start

Secondary outcomes (2)

Implantation Rate
Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred.
Measured: 4-5 weeks after treatment start
Delivery Rate
Measured: nearly 9 months after treatment start

Timeline

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

Dec 2008Feb 2012

First posted23 Jan 2009 (estimated)
Study startDec 2008
Primary completionJul 2011
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for In Vitro FertilizationStudies 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: 800 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00828191
Sponsor's protocol ID: 07USA/Prg05
Status last verified: Jan 2013
First submitted: 22 Jan 2009
Last updated: 31 Jan 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Griesinger G, Trevisan S, Cometti B. Endometrial thickness on the day of embryo transfer is a poor predictor of IVF treatment outcome. Hum Reprod Open. 2018 Jan 29;2018(1):hox031. doi: 10.1093/hropen/hox031. eCollection 2018.
PubMed 30895243
Baker VL, Jones CA, Doody K, Foulk R, Yee B, Adamson GD, Cometti B, DeVane G, Hubert G, Trevisan S, Hoehler F, Jones C, Soules M. A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization. Hum Reprod. 2014 Oct 10;29(10):2212-20. doi: 10.1093/humrep/deu194. Epub 2014 Aug 6.
PubMed 25100106

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
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RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
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RecruitingPhase 3
Fertilo In Vitro Research Study and Trial
In Vitro Maturation of Oocytes

All In Vitro Fertilization trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)
ClinicalTrials.gov ID: NCT00828191
Acronym / sponsor ID: 07USA/Prg05
Conditions: In Vitro Fertilization
Keywords: Luteal support in IVF
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 800 participants (actual)
Lead sponsor: IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Jul 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 23 Jan 2009 (estimated)
Results: Posted 26 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Progesterone SC	Experimental	Drug: Progesterone
Progesterone Tablets	Active comparator	Drug: Progesterone

Who may qualify

Ages: 18 to 42 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Patient has given written informed consent;
BMI < 30 kg/m2;
Age 18 - 42 (upon starting COH);
<3 prior ART cycles (IVF, ICSI and related procedures);
Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;

Key exclusion criteria (21 listed)

Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
Stage III or IV endometriosis (no endometriomas);
Hydrosalpinges;
History of past poor response to COH resulting in canceling ART;
Use of thawed/donated oocytes;

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
Progesterone25 mg, once a day, SC	Drug	Progesterone SC
Progesterone100 mg, twice a day, vaginally	Drug	Progesterone Tablets

Primary outcome

Ongoing Pregnancy Rate
Time frame: 10 weeks after treatment start

2 secondary outcomes

Implantation Rate
Time frame: 4-5 weeks after treatment start
Delivery Rate
Time frame: nearly 9 months after treatment start

Results and safety

Results posted to the registry on 26 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Progesterone SC	400	392
Progesterone Tablets	400	390

Primary outcome: Ongoing Pregnancy Rate

Time frame: 10 weeks after treatment start. Number. Unit: percentage of randomized patients

Measure	Progesterone SC n = 400	Progesterone Tablets n = 400
Value	40.8	43.3

Progesterone SC vs Progesterone Tablets: Difference in pregnancy rates: -2.5 (95% CI -9.4 to 4.4), p = 0.52, Fisher Exact

Population analysed: All randomized patients were included in the analysis

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Progesterone SC	0 of 400 (0%)	156 of 400 (39%)	Not reported
Progesterone Tablets	0 of 400 (0%)	161 of 400 (40.3%)	Not reported

Limitations and caveats (from the sponsor): No limitations of the trial reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30895243Griesinger G, Trevisan S, Cometti B. Endometrial thickness on the day of embryo transfer is a poor predictor of IVF treatment outcome. Hum Reprod Open. 2018 Jan 29;2018(1):hox031. doi: 10.1093/hropen/hox031. eCollection 2018.
Derived from this study: PubMed 25100106Baker VL, Jones CA, Doody K, Foulk R, Yee B, Adamson GD, Cometti B, DeVane G, Hubert G, Trevisan S, Hoehler F, Jones C, Soules M. A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization. Hum Reprod. 2014 Oct 10;29(10):2212-20. doi: 10.1093/humrep/deu194. Epub 2014 Aug 6.

Related trials for In Vitro Fertilization

RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
RecruitingPhase 3
Fertilo In Vitro Research Study and Trial
In Vitro Maturation of Oocytes

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.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Progesterone in people with In Vitro Fertilization, run by IBSA Institut Biochimique SA at 8 sites in United States.

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 7 inclusion and 21 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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?

Yes. Results are posted in the registry (first posted 26 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ongoing Pregnancy Rate (time frame: 10 weeks after treatment start). 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 NCT00828191, which also lists 2 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 31 Jan 2013.