InfertilityPhase 2PROGEXNCT03701490
Prolutex in Frozen Embryo Transfer Cycles At the Blastocyst Stage (PROGEX)
A Phase 2 study testing Progesterone subcutaneous and Progesterone Vaginal Product in people with Infertility, run by IBSA Institut Biochimique SA at 3 sites in Spain.
Trial summary
The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical pregnancy rate in women undergoing frozen embryo… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Progesterone subcutaneous and Progesterone Vaginal Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 3 sitesSpain
- Study dates
- 12 Mar 2019to 3 Dec 2022
- Phase
- Phase 2
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women attending the clinics to undergo a frozen blastocyst embryo transfer, having given written informed consent, with the following characteristics:
- 18-49 years of age for subjects undergoing ET with donated oocytes (both inclusive);
- 18-37 years of age for subjects undergoing ET with autologous oocytes (both inclusive);
- BMI <32 kg/m2;
- Adequate endometrium preparation (Endometrial thickness > 7 mm) and E2 levels ( >100 pg/ml) on the day progesterone treatment is started;
- P4 levels <1.5 ng/ml on the day progesterone treatment is started;
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- Transfer of 1 or 2 frozen embryos at blastocyst stage
- Transfer of frozen embryos of quality A and/or B according to Gardner criteria1;
- Semen from ejaculation either from the partner or from a bank
- ≤ 3 previous ET (frozen and fresh) with no pregnancy
- Normal uterine cavity (i.e. no polyp or protruding sub-mucosal fibroid).
Who cannot join
- Presence of functional follicles > 10 mm of diameter on the day progesterone treatment is started;
- Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
- Stage III or IV endometriosis (endometriomas);
- Hydrosalpinx;
- Pregnancy or lactation
- Malformations of the sexual organs incompatible with pregnancy;
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- Patients affected by pathologies associated with any contraindication of being pregnant;
- Known allergy to progesterone preparations or their excipients;
- Uncontrolled adrenal or thyroid dysfunction;
- Undiagnosed vaginal haemorrhage;
- History of, or current arterial disease;
- Patients with hepatic impairment;
- HIV, Hepatitis B Virus or Hepatitis C Virus seropositive;
- Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- High grade cervical dysplasia;
- Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
- Currently dependent on alcohol, drugs or psychotropic drugs
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on transvaginal ultrasonography;
- Participation in a concurrent clinical trial or another trial within the past 2 months;
- Use of concomitant medications that might interfere with the study evaluation: hormonal treatments other than those used in the study, except thyroid hormones.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Instituto Bernabeu
Alicante, 03016
Instituto Bernabeu Madrid
Madrid, 28001
Ginemed
Seville, 41010
About this study
Official title: A Proof of Concept, Randomized, Controlled Clinical Trial to Assess the Efficacy of Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone (Progeffik) for Endometrial Preparation in Women Undergoing Frozen Embryo Transfer(FET) Cycles
The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical pregnancy rate in women undergoing frozen embryo transfer (FET) at blastocyst stage.
- Conditions
- Infertility
- Being tested
- Progesterone subcutaneous, Progesterone Vaginal Product
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone subcutaneousDrug
25 mg/twice a day.
Progesterone Vaginal ProductDrug
200 mg three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Prolutex | Experimental | Not described Receives: Drug: Progesterone subcutaneous |
| Progeffik | Experimental | Not described Receives: Drug: Progesterone Vaginal Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 4-5 weeks after progesterone treatment start.
Secondary outcomes (6)
Serum progesterone level
Measured: 19+/-2 days and 4-5 weeks after start progesterone treatment
Frequency of uterine contractions
n of uterine contraction/min
Measured: on the day of Embryo transfer (i.e. 5 days after start progesterone treatment)
Positive serum pregnancy (beta-hCG) test rate
Measured: 19+/-2 days after start progesterone treatment
Implantation rate
Measured: 4-5 weeks after start progesterone treatment.
Ongoing pregnancy rate
Measured: 9-11 weeks after start progesterone treatment.
Abortion rate
Measured: 9 months after start progesterone treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start12 Mar 2019
- Primary completion28 Sep 2022
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701490
- Sponsor's protocol ID
- 18E-Prg06
- Acronym
- PROGEX
- Status last verified
- Feb 2023
- First submitted
- 8 Oct 2018
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept, Randomized, Controlled Clinical Trial to Assess the Efficacy of Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone (Progeffik) for Endometrial Preparation in Women Undergoing Frozen Embryo Transfer(FET) Cycles
- ClinicalTrials.gov ID
- NCT03701490
- Acronym / sponsor ID
- PROGEX / 18E-Prg06
- Conditions
- Infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 10 Oct 2018 (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.
The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical pregnancy rate in women undergoing frozen embryo transfer (FET) at blastocyst stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolutex | Experimental | Drug: Progesterone subcutaneous |
| Progeffik | Experimental | Drug: Progesterone Vaginal Product |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Women attending the clinics to undergo a frozen blastocyst embryo transfer, having given written informed consent, with the following characteristics:
- 18-49 years of age for subjects undergoing ET with donated oocytes (both inclusive);
- 18-37 years of age for subjects undergoing ET with autologous oocytes (both inclusive);
- BMI <32 kg/m2;
- Adequate endometrium preparation (Endometrial thickness > 7 mm) and E2 levels ( >100 pg/ml) on the day progesterone treatment is started;
Key exclusion criteria (20 listed)
- Presence of functional follicles > 10 mm of diameter on the day progesterone treatment is started;
- Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
- Stage III or IV endometriosis (endometriomas);
- Hydrosalpinx;
- Pregnancy or lactation
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 |
|---|---|---|
| Progesterone subcutaneous25 mg/twice a day. | Drug | Prolutex |
| Progesterone Vaginal Product200 mg three times a day. | Drug | Progeffik |
Primary outcome
Clinical pregnancy rate
Time frame: 4-5 weeks after progesterone treatment start.
6 secondary outcomes
Serum progesterone level
Time frame: 19+/-2 days and 4-5 weeks after start progesterone treatment
Frequency of uterine contractions
Time frame: on the day of Embryo transfer (i.e. 5 days after start progesterone treatment)
Positive serum pregnancy (beta-hCG) test rate
Time frame: 19+/-2 days after start progesterone treatment
Implantation rate
Time frame: 4-5 weeks after start progesterone treatment.
Ongoing pregnancy rate
Time frame: 9-11 weeks after start progesterone treatment.
Abortion rate
Time frame: 9 months after start progesterone treatment.
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 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progesterone subcutaneous and Progesterone Vaginal Product in people with Infertility, run by IBSA Institut Biochimique SA at 3 sites in Spain.
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 11 inclusion and 20 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 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical pregnancy rate (time frame: 4-5 weeks after progesterone treatment start.). 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 22 Nov 2024.