InfertilityPhase 4NCT00844311
Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation
A Phase 4 study testing rFSH and human chorionic gonadotropin in people with Infertility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this trial is to study whether addition of different doses of human chorionic gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve the number of top-quality embryos. Read more about this study
- Who is it for?
- Ages 25 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- rFSH and human chorionic gonadotropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2009to Jun 2010
- 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 25 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with indication for COS and IVF;
- Age between 25-37 years;
- BMI >18 and < 30 kg/m2;
- A regular menstrual cycle between 24 and 35 days and presumed to be ovulatory;
- Two ovaries;
- Tubal or unexplained infertility, including endometriosis stage I/II;
Show all 12Show fewer
- A uterus consistent with expected normal function (e.g. no clinically interfering uterine fibroids) documented by transvaginal ultrasound at the screening;
- Male partner with sperm quality compatible with fertilization via IVF procedure or previous clinical pregnancy;
- Early follicular phase serum FSH levels of 1-12 IU/l;
- Early follicular phase total antral follicle (2-10mm) count ≥ 6;
- Confirmation of down-regulation before randomisation by transvaginal ultrasound;
- Willing and able to sign informed consent.
Who cannot join
- History of or current PCOS, endometriosis stage III/IV or severe male factor requiring ICSI;
- History of severe ovarian hyperstimulation syndrome (OHSS);
- Presence of unilateral or bilateral hydrosalpinx at ultrasound;
- More than three previously COS cycles;
- Previous poor response on an IVF-cycle, defined as >20 days of gonadotrophin stimulation, cancellation due to limited follicular response or less than four follicles of ³15 mm diameter;
- Previous IVF cycle with unsuccessful fertilization, defined as fertilisation of £20% of the retrieved oocytes;
Show all 17Show fewer
- History of recurrent miscarriage;
- FSH>12IU/L or LH>12UI/L (early follicular phase);
- Contraindications for the use of gonadotropins or GnRH analogues;
- Recent history of current epilepsy, HIV infection, diabetes or cardiovascular gastrointestinal, hepatic, renal or pulmonary disease;
- Pregnancy, lactation or contraindication to pregnancy;
- Current past (last 12 months) abuse of alcohol or drugs;
- History of chemotherapy (except for gestational conditions) of radiotherapy;
- Undiagnosed vaginal bleeding;
- Tumours of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy;
- Abnormal karyotyping of the patient (if karyotyping is performed);
- Hypersensitivity to any trial product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplementation With hCG During Controlled Ovarian Stimulation With Recombinant FSH for in Vitro Fertilisation. A Randomized Controlled Clinical Study. Clinical, Embryological, Endocrine and Genetic Aspects.
The purpose of this trial is to study whether addition of different doses of human chorionic gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve the number of top-quality embryos.
- Conditions
- Infertility
- Being tested
- rFSH, human chorionic gonadotropin
- Keywords
- hCG, human chorionic gonadotropin
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFSHDrug
150 iu/day of rFSH
human chorionic gonadotropinDrug
50 iu/day of hCG from stimulation day 1
human chorionic gonadotropinDrug
100 iu/day of hCG from stimulation day 1
human chorionic gonadotropinDrug
150 iu/day of hCG from stimulation day 1
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | 150 iu/day of rFSH alone Receives: Drug: rFSH |
| hCG low dose | Experimental | 150 iu/day of rFSH + 50 iu/day of hCG from stimulation day 1 Receives: Drug: rFSH; Drug: human chorionic gonadotropin |
| hCG medium dose | Experimental | 150 iu/day of rFSH + 100 iu/day of hCG from stimulation day 1 Receives: Drug: rFSH; Drug: human chorionic gonadotropin |
| hCG high dose | Experimental | 150 iu/day of rFSH + 150 iu/day of hCG from stimulation day 1 Receives: Drug: rFSH; Drug: human chorionic gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of top-quality embryos at day 3
Secondary outcomes (1)
Implantation rate; Dose of rFSH needed; Serum levels of endocrine parameters; Ongoing pregnancy; Follicular fluid levels of endocrine parameters and cytokines; Expressions of gene families in granulosa cells and the cumulus complex.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844311
- Sponsor's protocol ID
- 2008-257
- Status last verified
- Feb 2009
- First submitted
- 13 Feb 2009
- Last updated
- 4 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thuesen LL, Andersen AN, Loft A, Smitz J. Intrafollicular endocrine milieu after addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization. J Clin Endocrinol Metab. 2014 Feb;99(2):517-26. doi: 10.1210/jc.2013-1528. Epub 2013 Dec 2.
PubMed 24297796Thuesen LL, Loft A, Egeberg AN, Smitz J, Petersen JH, Andersen AN. A randomized controlled dose-response pilot study of addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization. Hum Reprod. 2012 Oct;27(10):3074-84. doi: 10.1093/humrep/des256. Epub 2012 Jul 12.
PubMed 22791754
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With hCG During Controlled Ovarian Stimulation With Recombinant FSH for in Vitro Fertilisation. A Randomized Controlled Clinical Study. Clinical, Embryological, Endocrine and Genetic Aspects.
- ClinicalTrials.gov ID
- NCT00844311
- Acronym / sponsor ID
- 2008-257
- Conditions
- Infertility
- Keywords
- hCG, human chorionic gonadotropin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Feb 2009 (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 trial is to study whether addition of different doses of human chorionic gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve the number of top-quality embryos.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Drug: rFSH150 iu/day of rFSH alone |
| hCG low dose | Experimental | Drug: rFSH, Drug: human chorionic gonadotropin150 iu/day of rFSH + 50 iu/day of hCG from stimulation day 1 |
| hCG medium dose | Experimental | Drug: rFSH, Drug: human chorionic gonadotropin150 iu/day of rFSH + 100 iu/day of hCG from stimulation day 1 |
| hCG high dose | Experimental | Drug: rFSH, Drug: human chorionic gonadotropin150 iu/day of rFSH + 150 iu/day of hCG from stimulation day 1 |
Who may qualify
- Ages
- 25 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Females with indication for COS and IVF;
- Age between 25-37 years;
- BMI >18 and < 30 kg/m2;
- A regular menstrual cycle between 24 and 35 days and presumed to be ovulatory;
- Two ovaries;
Key exclusion criteria (17 listed)
- History of or current PCOS, endometriosis stage III/IV or severe male factor requiring ICSI;
- History of severe ovarian hyperstimulation syndrome (OHSS);
- Presence of unilateral or bilateral hydrosalpinx at ultrasound;
- More than three previously COS cycles;
- Previous poor response on an IVF-cycle, defined as >20 days of gonadotrophin stimulation, cancellation due to limited follicular response or less than four follicles of ³15 mm diameter;
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 |
|---|---|---|
| rFSH150 iu/day of rFSH | Drug | Control arm, hCG high dose, hCG low dose, hCG medium dose |
| human chorionic gonadotropin50 iu/day of hCG from stimulation day 1 | Drug | hCG low dose |
| human chorionic gonadotropin100 iu/day of hCG from stimulation day 1 | Drug | hCG medium dose |
| human chorionic gonadotropin150 iu/day of hCG from stimulation day 1 | Drug | hCG high dose |
Primary outcome
Total number of top-quality embryos at day 3
1 secondary outcome
Implantation rate; Dose of rFSH needed; Serum levels of endocrine parameters; Ongoing pregnancy; Follicular fluid levels of endocrine parameters and cytokines; Expressions of gene families in granulosa cells and the cumulus complex.
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 4 Aug 2010.
- Derived from this study: PubMed 24297796Thuesen LL, Andersen AN, Loft A, Smitz J. Intrafollicular endocrine milieu after addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization. J Clin Endocrinol Metab. 2014 Feb;99(2):517-26. doi: 10.1210/jc.2013-1528. Epub 2013 Dec 2.
- Derived from this study: PubMed 22791754Thuesen LL, Loft A, Egeberg AN, Smitz J, Petersen JH, Andersen AN. A randomized controlled dose-response pilot study of addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization. Hum Reprod. 2012 Oct;27(10):3074-84. doi: 10.1093/humrep/des256. Epub 2012 Jul 12.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rFSH and human chorionic gonadotropin in people with Infertility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 12 inclusion and 17 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 4 Aug 2010. 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 Denmark. 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?
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?
Total number of top-quality embryos at day 3. 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 NCT00844311, 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 4 Aug 2010.