Luteal Phase DefectNCT01178931
Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support
A study testing Oral dydrogesterone and Crinone 8% gel in people with Luteal Phase Defect, run by University of Zagreb at 1 site in Croatia.
Trial summary
The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support. (Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Luteal Phase Defect
- What is being tested?
- Oral dydrogesterone and Crinone 8% gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 853 participants
- Where
- 1 siteCroatia
- Study dates
- Oct 2010to Dec 2013
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- routine ovulation induction protocol with GnRH agonist
- less than three prior IVF cycles
- at least three aspirated oocytes
- BMI <35 kg/m2
- age <45 years
Who cannot join
- history of dysfunctional uterine bleeding
- acute urogenital disease
- recurrent miscarriage
- previous allergic reactions to a progesterone products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial
The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support.
(Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)
Read the detailed description
The use of gonadotropin-releasing hormone (GnRH) agonists in the ovarian stimulation, which prevents a premature surge of luteal hormone (LH), ultimately leads to suppression of the pituitary gland and high levels of estrogen observed during induced cycles result in inhibiting effect on the implantation of human embryos.
The luteal support in in-vitro-fertilization (IVF) cycles can be prolonged using human chorion gonadotropin(hCG) and/or progesterone.
Since it has been noted that the use of hCG was related with higher risks of the onset of ovarian hyperstimulation syndrome (OHSS), progesterone is nowadays a product of choice in luteal support.
Currently vaginal progesterone is widely used, since the classic oral progesterone results in low bioavailability and lower pregnancy rate and the intramuscular progesterone (IM-P) daily injections are painful and may cause abscesses, inflammatory reactions and local soreness.
However, standard protocol for luteal phase support has not been established (i.e. optimal dosage, route or duration).
Dydrogesterone is a retroprogesterone with good oral bioavailability. Oral administration is clear advantage, due to expected higher patient compliance and better tolerability than currently used vaginal or IM-P.
We hypothesize that dydrogesterone has the same efficacy as vaginal progesterone but better tolerability due to less side effects.
- Conditions
- Luteal Phase Defect
- Being tested
- Oral dydrogesterone, Crinone 8% gel
- Keywords
- IVF, luteal phase support, oral progesterone, vaginal progesterone, pregnancy rate, safety, tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral dydrogesteroneDrug
Also called Duphastone (Solvay Pharmaceuticals)
oral-2x10mg
Crinone 8% gelDrug
Also called Crinone 8% gel (Fleet Laboratories Ltd., Watford, UK)
vaginal-1x90mg
| Study group | Role | What they receive |
|---|---|---|
| Oral dydrogesterone | Active comparator | Study group receiving 2x10mg of oral dydrogesterone until a pregnancy test or in the case of pregnancy until 10 week. Receives: Drug: Oral dydrogesterone |
| Crinone 8% vaginal gel | Active comparator | Control group is receiving vaginal gel, 1x90mg, until a pregnancy test or in the case of pregnancy until 10 week. Receives: Drug: Crinone 8% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Ongoing pregnancy rate is defined by the presence of gestational sac(s) with viable fetal heart beats at 12 weeks' gestation by transvaginal ultrasound.
Measured: 12 weeks
Secondary outcomes (2)
Number of participants with adverse events
The side effects included the occurrence of headache, somnolence, nausea, abdominal pain, bloating, dizziness, headache, breast fullness, perineal irritation, vaginal discharge and bleeding, interference with coitus.
Measured: 10 weeks
Satisfaction
Satisfaction score is determinate on the 5-point level scale with 1 being "absolutely satisfied" and 5 being "absolutely dissatisfied" and tolerability by yes and now answers regarding side effects that the supplements could cause.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Luteal Phase DefectStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 853 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vlatka Tomic, University of Zagreb
- Investigators
- Jozo Tomic, M.D., Principal investigator, Department of Human Reproduction, University Hospital Center Sisters of MercyVlatka Tomic, M.D., Study chair, Department of Human Reproduction, University Hospital Center Sisters of Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178931
- Sponsor's protocol ID
- KBSM-0010
- Status last verified
- Jan 2014
- First submitted
- 9 Aug 2010
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tomic V, Tomic J, Klaic DZ, Kasum M, Kuna K. Oral dydrogesterone versus vaginal progesterone gel in the luteal phase support: randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:49-53. doi: 10.1016/j.ejogrb.2014.11.002. Epub 2014 Nov 20.
PubMed 25622239
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01178931
- Acronym / sponsor ID
- KBSM-0010
- Conditions
- Luteal Phase Defect
- Keywords
- IVF, luteal phase support, oral progesterone, vaginal progesterone, pregnancy rate, safety, tolerability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 853 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Aug 2010 (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 study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support.
(Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)
Detailed description
The use of gonadotropin-releasing hormone (GnRH) agonists in the ovarian stimulation, which prevents a premature surge of luteal hormone (LH), ultimately leads to suppression of the pituitary gland and high levels of estrogen observed during induced cycles result in inhibiting effect on the implantation of human embryos.
The luteal support in in-vitro-fertilization (IVF) cycles can be prolonged using human chorion gonadotropin(hCG) and/or progesterone.
Since it has been noted that the use of hCG was related with higher risks of the onset of ovarian hyperstimulation syndrome (OHSS), progesterone is nowadays a product of choice in luteal support.
Currently vaginal progesterone is widely used, since the classic oral progesterone results in low bioavailability and lower pregnancy rate and the intramuscular progesterone (IM-P) daily injections are painful and may cause abscesses, inflammatory reactions and local soreness.
However, standard protocol for luteal phase support has not been established (i.e. optimal dosage, route or duration).
Dydrogesterone is a retroprogesterone with good oral bioavailability. Oral administration is clear advantage, due to expected higher patient compliance and better tolerability than currently used vaginal or IM-P.
We hypothesize that dydrogesterone has the same efficacy as vaginal progesterone but better tolerability due to less side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral dydrogesterone | Active comparator | Drug: Oral dydrogesteroneStudy group receiving 2x10mg of oral dydrogesterone until a pregnancy test or in the case of pregnancy until 10 week. |
| Crinone 8% vaginal gel | Active comparator | Drug: Crinone 8% gelControl group is receiving vaginal gel, 1x90mg, until a pregnancy test or in the case of pregnancy until 10 week. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- routine ovulation induction protocol with GnRH agonist
- less than three prior IVF cycles
- at least three aspirated oocytes
- BMI <35 kg/m2
- age <45 years
Key exclusion criteria (4 listed)
- history of dysfunctional uterine bleeding
- acute urogenital disease
- recurrent miscarriage
- previous allergic reactions to a progesterone products
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 |
|---|---|---|
| Oral dydrogesteroneAlso: Duphastone (Solvay Pharmaceuticals)oral-2x10mg | Drug | Oral dydrogesterone |
| Crinone 8% gelAlso: Crinone 8% gel (Fleet Laboratories Ltd., Watford, UK)vaginal-1x90mg | Drug | Crinone 8% vaginal gel |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks
Ongoing pregnancy rate is defined by the presence of gestational sac(s) with viable fetal heart beats at 12 weeks' gestation by transvaginal ultrasound.
2 secondary outcomes
Number of participants with adverse events
Time frame: 10 weeks
Satisfaction
Time frame: 10 weeks
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 29 Jan 2014.
- Derived from this study: PubMed 25622239Tomic V, Tomic J, Klaic DZ, Kasum M, Kuna K. Oral dydrogesterone versus vaginal progesterone gel in the luteal phase support: randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:49-53. doi: 10.1016/j.ejogrb.2014.11.002. Epub 2014 Nov 20.
Related trials for Luteal Phase Defect
RecruitingPhase 4
Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment
Pregnancy Related, Fertility Issues
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.
Jozo Tomic, M.D. principal investigator
Department of Human Reproduction, University Hospital Center Sisters of Mercy
Vlatka Tomic, M.D. study chair
Department of Human Reproduction, University Hospital Center Sisters of Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral dydrogesterone and Crinone 8% gel in people with Luteal Phase Defect, run by University of Zagreb at 1 site in Croatia.
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 5 inclusion and 4 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 29 Jan 2014. 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 Croatia. 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.
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?
Ongoing pregnancy rate (time frame: 12 weeks). 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 NCT01178931, which also lists 1 linked publication.
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 29 Jan 2014.