Evidence map›Paper›PMID 23249758›Full record

Trial reportReproductive biology and endocrinology : RB&E2012

Clomiphene citrate versus high doses of gonadotropins for in vitro fertilisation in women with compromised ovarian reserve: a randomised controlled non-inferiority trial.

Guido Ragni, Paolo E Levi-Setti, Rubens Fadini, Claudio Brigante, Claudia Scarduelli, Federica Alagna, Veronica Arfuso, Mario Mignini-Renzini, Massimo Candiani, Alessio Paffoni and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Reproductive biology and endocrinology : RB&E, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01389713 (Patients With Reduced Ovarian Reserve and In Vitro Fertilization), which is not on this map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 pooled it
1.4field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01389713 nacompletednot on this map

Patients With Reduced Ovarian Reserve and In Vitro Fertilization (IVF) Cycles. A Randomized Multicentric Comparison of a Protocol With High Doses of Gonadotropins and a Protocol With Clomiphene Citrate Only. Evaluation of Clinical Effectiveness and Economic Issues

TypeinterventionalSponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoRan2008 to 2010Enrolled289ConditionsInfertilityArmsClomifene Citrate, GnRH analog and recombinant human FSH
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 4 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
  7. Article
  8. Observational
  9. Editorial: The Expansion of Female Fertility.Frontiers in reproductive health · 2021
    Article
  10. Article
  11. Article
  12. Article
  13. Minimal Stimulation In Vitro Fertilization: A Better Outcome.International journal of fertility & sterility
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Guido RagniInfertility Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy.
Paolo E Levi-Setti
Rubens Fadini
Claudio Brigante
Claudia Scarduelli
Federica Alagna
Veronica Arfuso
Mario Mignini-Renzini
Massimo Candiani
Alessio Paffoni
Edgardo Somigliana
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIRCCS Humanitas Research Hospital · ITIRCCS Ospedale San Raffaele · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of the present randomised controlled non-inferiority trial is to test whether in women with compromised ovarian reserve requiring in vitro fertilisation, a protocol of ovarian stimulation using exclusively clomiphene citrate performs similarly to a regimen with high doses of gonadotropins.

methodsWomen with day 3 serum FSH > 12 IU/ml on at least two occasions or previous poor response to hyper-stimulation were recruited at four Italian infertility units. Selected women were allocated to clomiphene citrate 150 mg/day from day 3 to day 7 of the cycle (n=145) or to a short protocol with GnRH agonist 0.1 mg and recombinant FSH 450 IU daily (n=146). They were randomised by means of a computer-generated list into two groups. The study was not blinded. The main outcome of the study was the delivery rate per started cycle.

resultsThe study was interrupted after the scheduled two years of recruitment before reaching the sample size. 148 women were allocated to clomiphene citrate and 156 to the short protocol with high doses of gonadotropins; 124 and 125 participants were analysed in the groups, respectively. Women allocated to high doses of gonadotropins retrieved more oocytes and had a higher probability to perform embryo-transfer. However, the chances of success were similar. The delivery rate per started cycle in women receiving clomiphene citrate and high-dose gonadotropins was 3% (n=5) and 5% (n=7), respectively (p=0.77). The mean estimated cost per delivery in the two groups was 81,294 and 113,107 Euros, respectively. No side-effects or adverse events were observed.

conclusionsIn women with compromised ovarian reserve selected for in vitro fertilisation, ovarian stimulation with clomiphene citrate or high-dose gonadotropins led to similar chances of pregnancy but the former is less expensive.

trial registrationTrial registered on http://www.clinicaltrials.gov (NCT01389713).

Indexed as

AdultClomipheneDose-Response Relationship, DrugFemaleFertility Agents, FemaleFertilization in VitroGonadotropinsHumansInfertility, FemaleOvulation InductionPregnancyClomipheneFertility Agents, FemaleGonadotropins

Identifiers

PMID23249758
PMCPMC3551801
OpenAlexW2166169434

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.