InfertilityPhase 3ESTHER-1NCT01956110
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1
A Phase 3 study testing Follitropin Delta (FE 999049) and Follitropin Alfa (GONAL-F) in people with Infertility, run by Ferring Pharmaceuticals at 13 sites in 11 countries.
Trial summary
This trial investigates the effects of FE 999049 compared to GONAL-F. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Follitropin Delta (FE 999049) and Follitropin Alfa (GONAL-F)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,329 participants
- Where
- 13 sitesin 11 countries
- Study dates
- Oct 2013to 3 Jan 2017
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed Consent Documents signed prior to screening evaluations
- In good physical and mental health
- Pre-menopausal females between the ages of 18 and 40 years
- Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor
- Infertility for at least one year before randomisation for subjects ≤37 years or for at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe male factor infertility)
- The trial cycle will be the subject's first controlled ovarian stimulation cycle for IVF/ICSI
Show all 10Show fewer
- Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomisation
- Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be accessible for oocyte retrieval.
- Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomisation)
- Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening
Who cannot join
- Known endometriosis stage III-IV
- One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to randomisation on stimulation day 1
- Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy)
- Known abnormal karyotype of subject or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial.
- Any known clinically significant systemic disease (e.g. insulin-dependent diabetes)
- Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease
- Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
Trial locations and contacts
13 sites in 11 countries.
13 sites in 11 countries
Canada3 sites
Pacific Centre for Reproductive Medicine
Burnaby, British Columbia
Ottawa Fertility Centre
Ottawa, Ontario
Olive Fertility Centre
Vancouver, British Columbia
Brazil1 site
Fertilitat and PUC-RS (there may be other sites in this country)
Porto Alegre
Denmark1 site
Rigshospitalet Fertilitetsklinikken (there may be other sites in this country)
Copenhagen
France1 site
Department of Endocrine Gynaecology and Reproductive Medicine, Hôpital Jeanne de Flandre (there may be other sites in this country)
Lille
Italy1 site
Centro Natalità San Raffaele (there may be other sites in this country)
Milan
Poland1 site
The nOvum Clinic (there may be other sites in this country)
Warsaw
Russia1 site
IVF & Reproductive Genetics Center (there may be other sites in this country)
Moscow
United Kingdom1 site
Glasgow Centre for Reproductive Medicine Ltd. (there may be other sites in this country)
Glasgow
About this study
Official title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
This trial investigates the effects of FE 999049 compared to GONAL-F.
- Conditions
- Infertility
- Being tested
- Follitropin Delta (FE 999049), Follitropin Alfa (GONAL-F)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin Delta (FE 999049)Drug
Follitropin Alfa (GONAL-F)Drug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Follitropin Delta (FE 999049) Receives: Drug: Follitropin Delta (FE 999049) |
| B | Active comparator | Follitropin Alfa (GONAL-F) Receives: Drug: Follitropin Alfa (GONAL-F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy Rate
Ongoing pregnancy was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer.
Measured: 10-11 weeks after blastocyst transfer
Ongoing Implantation Rate
Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred.
Measured: 10-11 weeks after blastocyst transfer
Secondary outcomes (21)
Vital Pregnancy Rate
Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer.
Measured: 5-6 weeks after blastocyst transfer
Implantation Rate
Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred.
Measured: 5-6 weeks after blastocyst transfer
Proportion of Subjects With Extreme Ovarian Responses, Defined as <4, ≥15 or ≥20 Oocytes Retrieved
Measured: Day of oocyte retrieval
Proportion of Subjects With Early OHSS (Ovarian Hyperstimulation Syndrome) and/or Preventive Interventions for Early OHSS
The proportion of subjects with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.
Measured: ≤9 days after triggering of final follicular maturation
Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response
Proportion of subjects with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented.
Measured: End-of-stimulation (up to 20 stimulation days)
Number of Oocytes Retrieved
Measured: Day of oocyte retrieval
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Measured: Day of oocyte retrieval
Percentage of Metaphase II Oocytes (Oocytes Inseminated Using ICSI [Intracytoplasmic Sperm Injection])
Number of oocytes in metaphase II prior to ICSI insemination is presented.
Measured: Prior to insemination
Fertilisation Rate
Fertilisation rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.
Measured: Day 1 after insemination
Number and Quality of Embryos on Day 3
Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and fragmentation ≤20% on Day 3.
Measured: On day 3 after oocyte retrieval
Number and Quality of Blastocysts on Day 5
Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.
Measured: On day 5 after oocyte retrieval
Total Gonadotropin Dose
The total gonadotropin dose was recorded.
Measured: End-of-stimulation (up to 20 stimulation days)
Number of Stimulation Days
Measured: End-of-stimulation (up to 20 stimulation days)
Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments
Measured: End-of-stimulation (up to 20 stimulation days)
Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period
Subjects self-assessed injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after each injection. The injection site reactions were assessed as none, mild, moderate and severe. The frequency of injection site reactions (mild, moderate or severe) based on all assessments performed is presented.
Measured: End-of-stimulation (up to 20 stimulation days)
Abdominal Discomfort Related to Controlled Ovarian Stimulation as Assessed by a Visual Analogue Scale (VAS)
The subject self-assessed abdominal discomfort related to controlled ovarian stimulation using a VAS going from 0 mm (no abdominal discomfort) to 100 mm (worst imaginable abdominal discomfort).
Measured: End-of-stimulation and day of blastocyst transfer
Changes in Body Weight
Change in body weight from baseline to end-of-stimulation and from baseline to day of blastocyst transfer.
Measured: End-of-stimulation and day of blastocyst transfer
Changes in Maximum Abdominal Circumference
Change in maximum abdominal circumference from baseline to end-of-stimulation and from baseline to day of blastocyst transfer.
Measured: End-of-stimulation and day of blastocyst transfer
Proportion of Subjects With Treatment-induced Anti-follicle-stimulating Hormone (FSH) Antibodies
The proportion of subjects with at least one treatment-induced anti-FSH antibody response at any time point.
Measured: Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose
Proportion of Subjects With Late OHSS
Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation.The proportion of subjects with late OHSS, and late OHSS of moderate or severe grade are presented.
Measured: >9 days after triggering of final follicular maturation
Technical Malfunctions of the Administration Pen
Confirmed technical malfunction of administration pen.
Measured: End-of-stimulation (up to 20 stimulation days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completion3 Jan 2017
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 (5)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956110
- Sponsor's protocol ID
- 000004
- Other IDs
- 2013-001669-17, U1111-1147-6826
- Acronym
- ESTHER-1
- Status last verified
- Sep 2018
- First submitted
- 16 Aug 2013
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.
PubMed 32819842Havelock J, Aaris Henningsen AK, Mannaerts B, Arce JC; ESTHER-1 and ESTHER-2 Trial Groups. Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta. J Assist Reprod Genet. 2021 Oct;38(10):2651-2661. doi: 10.1007/s10815-021-02271-5. Epub 2021 Jul 13.
PubMed 34254211Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2022 Jan;44(1):177-184. doi: 10.1016/j.rbmo.2021.09.014. Epub 2021 Sep 23.
PubMed 34799275Nelson SM, Larsson P, Mannaerts BMJL, Nyboe Andersen A, Fauser BCJM. Anti-Mullerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta. Clin Endocrinol (Oxf). 2019 May;90(5):719-726. doi: 10.1111/cen.13956. Epub 2019 Mar 18.
PubMed 30801744Nyboe Andersen A, Nelson SM, Fauser BC, Garcia-Velasco JA, Klein BM, Arce JC; ESTHER-1 study group. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-396.e4. doi: 10.1016/j.fertnstert.2016.10.033. Epub 2016 Nov 29.
PubMed 27912901
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
- ClinicalTrials.gov ID
- NCT01956110
- Acronym / sponsor ID
- ESTHER-1 / 000004
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,329 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial investigates the effects of FE 999049 compared to GONAL-F.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Follitropin Delta (FE 999049)Follitropin Delta (FE 999049) |
| B | Active comparator | Drug: Follitropin Alfa (GONAL-F)Follitropin Alfa (GONAL-F) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Informed Consent Documents signed prior to screening evaluations
- In good physical and mental health
- Pre-menopausal females between the ages of 18 and 40 years
- Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor
- Infertility for at least one year before randomisation for subjects ≤37 years or for at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe male factor infertility)
Key exclusion criteria (7 listed)
- Known endometriosis stage III-IV
- One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to randomisation on stimulation day 1
- Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy)
- Known abnormal karyotype of subject or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial.
- Any known clinically significant systemic disease (e.g. insulin-dependent diabetes)
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 |
|---|---|---|
| Follitropin Delta (FE 999049) | Drug | A |
| Follitropin Alfa (GONAL-F) | Drug | B |
Primary outcome
Ongoing Pregnancy Rate
Time frame: 10-11 weeks after blastocyst transfer
Ongoing pregnancy was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer.
Ongoing Implantation Rate
Time frame: 10-11 weeks after blastocyst transfer
Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred.
21 secondary outcomes
Vital Pregnancy Rate
Time frame: 5-6 weeks after blastocyst transfer
Implantation Rate
Time frame: 5-6 weeks after blastocyst transfer
Proportion of Subjects With Extreme Ovarian Responses, Defined as <4, ≥15 or ≥20 Oocytes Retrieved
Time frame: Day of oocyte retrieval
Proportion of Subjects With Early OHSS (Ovarian Hyperstimulation Syndrome) and/or Preventive Interventions for Early OHSS
Time frame: ≤9 days after triggering of final follicular maturation
Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response
Time frame: End-of-stimulation (up to 20 stimulation days)
Number of Oocytes Retrieved
Time frame: Day of oocyte retrieval
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Time frame: Day of oocyte retrieval
Percentage of Metaphase II Oocytes (Oocytes Inseminated Using ICSI [Intracytoplasmic Sperm Injection])
Time frame: Prior to insemination
Fertilisation Rate
Time frame: Day 1 after insemination
Number and Quality of Embryos on Day 3
Time frame: On day 3 after oocyte retrieval
Number and Quality of Blastocysts on Day 5
Time frame: On day 5 after oocyte retrieval
Total Gonadotropin Dose
Time frame: End-of-stimulation (up to 20 stimulation days)
Number of Stimulation Days
Time frame: End-of-stimulation (up to 20 stimulation days)
Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments
Time frame: End-of-stimulation (up to 20 stimulation days)
Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period
Time frame: End-of-stimulation (up to 20 stimulation days)
Abdominal Discomfort Related to Controlled Ovarian Stimulation as Assessed by a Visual Analogue Scale (VAS)
Time frame: End-of-stimulation and day of blastocyst transfer
Changes in Body Weight
Time frame: End-of-stimulation and day of blastocyst transfer
Changes in Maximum Abdominal Circumference
Time frame: End-of-stimulation and day of blastocyst transfer
Proportion of Subjects With Treatment-induced Anti-follicle-stimulating Hormone (FSH) Antibodies
Time frame: Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose
Proportion of Subjects With Late OHSS
Time frame: >9 days after triggering of final follicular maturation
Technical Malfunctions of the Administration Pen
Time frame: End-of-stimulation (up to 20 stimulation days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32819842Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.
- Results publication: PubMed 34254211Havelock J, Aaris Henningsen AK, Mannaerts B, Arce JC; ESTHER-1 and ESTHER-2 Trial Groups. Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta. J Assist Reprod Genet. 2021 Oct;38(10):2651-2661. doi: 10.1007/s10815-021-02271-5. Epub 2021 Jul 13.
- Results publication: PubMed 34799275Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2022 Jan;44(1):177-184. doi: 10.1016/j.rbmo.2021.09.014. Epub 2021 Sep 23.
- Derived from this study: PubMed 30801744Nelson SM, Larsson P, Mannaerts BMJL, Nyboe Andersen A, Fauser BCJM. Anti-Mullerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta. Clin Endocrinol (Oxf). 2019 May;90(5):719-726. doi: 10.1111/cen.13956. Epub 2019 Mar 18.
- Derived from this study: PubMed 27912901Nyboe Andersen A, Nelson SM, Fauser BC, Garcia-Velasco JA, Klein BM, Arce JC; ESTHER-1 study group. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-396.e4. doi: 10.1016/j.fertnstert.2016.10.033. Epub 2016 Nov 29.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
13 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Follitropin Delta (FE 999049) and Follitropin Alfa (GONAL-F) in people with Infertility, run by Ferring Pharmaceuticals at 13 sites in 11 countries.
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 10 inclusion and 7 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, Belgium, Brazil, Czechia, Denmark and 6 more countries. 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 25 Sep 2018). 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: 10-11 weeks after blastocyst transfer). The study lists 2 primary outcomes in all. 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 NCT01956110, which also lists 5 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 13 Jan 2022.